Articles from Alvotech

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025.

REYKJAVIK, Iceland, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its stock will be added to the Nasdaq Biotechnology Index NASDAQ: NBINASDAQNBI)

REYKJAVIK, Iceland, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first nine months of 2024 and provided a summary of recent corporate highlights.

REYKJAVIK, Iceland, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore’s HealthCONx Conference on Thursday, December 5, 2024 starting at 12:55 ET (17:55 GMT).

REYKJAVIK, Iceland and LONDON, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025.

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Thursday November 14, 2024, at 8:00 am ET (13:00 GMT).  

REYKJAVIK, Iceland, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on Tuesday, November 19, 2024 at 9:00-9:25 am GMT.

REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).

REYKJAVIK, Iceland, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio.

REYKJAVIK, Iceland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35 GMT).

REYKJAVIK, Iceland, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first six months of 2024 and provided a summary of recent corporate highlights.

REYKJAVIK, Iceland and LONDON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025.

REYKJAVIK, Iceland, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Friday August 16, 2024, at 8:00 am EDT (12 noon GMT).  

BAD VILBEL, Germany and REYKJAVIK, Iceland, July 22, 2024 (GLOBE NEWSWIRE) -- STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology. Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain.

REYKJAVIK, Iceland, July 11, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the closing of its previously announced senior secured first lien term loan facility (the “Facility”). The closing has allowed Alvotech to refinance outstanding debt obligations, reduce the cost of capital and improve its overall debt maturity profile.

REYKJAVIK, Iceland, July 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). The study met its primary endpoints. The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in postmenopausal women with osteoporosis. The results will be used to support additional indications for AVT03 as a proposed biosimilar to Xgeva, based on extrapolation.

REYKJAVIK, Iceland, July 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today issued new shares to holders of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, with maturity on December 20, 2025 (the “Convertible Bonds”).

REYKJAVIK, Iceland, July 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced certain preliminary, unaudited key financial information for the second quarter and six months ended June 30, 2024, as follows:

REYKJAVIK, Iceland , June 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that holders of the majority of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, respectively, with maturity on December 20, 2025 (the “Convertible Bonds”) have elected to convert the principal and accrued interest into ordinary shares of Alvotech at the fixed conversion price of US$10.00 per share on the last scheduled conversion date prior to maturity, which is July 1, 2024 (the “Conversion Date”).

REYKJAVIK, Iceland and LONDON, June 18, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29, a biosimilar candidate for Eylea® high dose (8 mg).

REYKJAVIK, Iceland and BAD VILBEL, Germany, June 11, 2024 (GLOBE NEWSWIRE) -- Alvotech and STADA are strengthening their existing strategic alliance for high-quality, cost-effective biosimilars by extending their partnership to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.

REYKJAVIK, Iceland, June 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the “Lenders”), will enable Alvotech (the “Company”) to improve cost of capital, address upcoming debt maturities in 2025 and enhance its financial flexibility by adding incremental cash to the balance sheet.

REYKJAVIK, Iceland, May 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 5-6, 2024. Alvotech will present and host investor and business meetings at the conference.

REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first three months of 2024 and provided a summary of recent corporate highlights.

HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia® and Xgeva® (denosumab). The collaboration combines Dr. Reddy’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for markets worldwide.

REYKJAVIK, Iceland and PARSIPPANY, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Alvotech (NASDAQALVO), today announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.

REYKJAVIK, Iceland, May 13, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024.

REYKJAVIK, Iceland, May 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of management would be participating in the upcoming BofA Securities Healthcare Conference 2024, which will be held on May 14-15, 2024 in Las Vegas, NV.

REYKJAVIK, Iceland and PARSIPPANY, N.J. and TEL AVIV, Israel, April 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), disclosed today that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira® (adalimumab) for Quallent Pharmaceuticals, in alignment with its U.S. commercialization agreement with Teva. The interchangeable biosimilar will be distributed under Quallent’s private label.

REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab). Alvotech is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study.

REYKJAVIK, Iceland, April 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration (FDA) approved high-concentration interchangeable biosimilar to Humira.

REYKJAVIK, Iceland and PARSIPPANY, N.J., April 16, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.

REYKJAVIK, Iceland, April 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will host an audio call with a market update at 12:15 pm GMT / 08:15 am EDT on April 3, 2024. Anil Okay, Chief Commercial Officer, will be providing the update.

REYKJAVIK, Iceland, March 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has increased the Company´s share capital by an amount of one hundred and thirty thousand (USD 130,000) by issuing thirteen million (13,000,000) ordinary shares. The Company’s subsidiary, Alvotech Manco ehf. (the “subsidiary”), has subscribed to all of the newly issued shares for a price of USD 15.98 per share. The shares held by the subsidiary are treated as treasury shares without voting rights or dividend entitlement.

REYKJAVIK, Iceland, March 20, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2023 and provided a summary of recent pipeline and corporate highlights. Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).

Alvotech to host Capital Markets Day in Reykjavik and on-line on March 22, 2024

REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer. Christina succeeds Sandra Casaca, who is leaving the company as a part of other organizational changes. Christina Siniscalchi has for over ten years served in senior quality positions for Alvogen and its manufacturing site in Norwich, NY, most recently as Alvogen’s Chief Quality Officer.

REYKJAVIK, Iceland, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has accepted an offer from investors (the “Investors”) for the sale of 10,127,132 of its ordinary shares, for an approximate value of USD 166 million, par value USD 0.01 per share (the “Shares”), at a purchase price of USD 16.41 per Share, or ISK 2,250 per share at foreign exchange rates on February 23, 2024 (the “Transaction”). The Shares are expected to be delivered to the Investors from previously issued treasury shares held by Alvotech’s subsidiary, Alvotech Manco ehf. The Transaction will be made on the Nasdaq Iceland Exchange.

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion[1]. Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

REYKJAVIK, Iceland, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara® (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending in additional global markets, including in the U.S.

REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.

REYKJAVIK, Iceland, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days.

BAD VILBEL, Germany and REYKJAVIK, Iceland, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

The confirmatory clinical, safety and efficacy study for AVT06, biosimilar candidate to Eylea® (aflibercept) met its primary endpoint in patients with neovascular (wet) Age-related Macular Degeneration (AMD)

The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint

REYKJAVIK, Iceland, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first nine months of 2023 and provided a summary of recent corporate highlights.

REYKJAVIK, ICELAND, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first nine months of 2023, after U.S. markets close on Tuesday, November 28, 2023.

PrJamtekiTM is the second biosimilar developed under this partnership that receives marketing authorization in Canada.

BAD VILBEL, Germany and REYKJAVIK, Iceland, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab).

REYKJAVIK, Iceland, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference taking place in London on November 14-16, 2023.

REYKJAVIK, Iceland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara® (ustekinumab).

REYKJAVIK, Iceland and PISCATAWAY, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed biosimilar to Xolair® (omalizumab), which is currently in clinical development.

REYKJAVIK, Iceland, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji”), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare. Based on publicly available information, AVT04 is the first biosimilar to Stelara to be approved for sale in global markets. Global sales of Stelara reached over $10 billion for the twelve months preceding June 30, 2023, according to the manufacturer’s public filings, making it one of the world’s highest grossing biologics.

REYKJAVIK, Iceland, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira® (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA.

REYKJAVIK, Iceland, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that Faysal Kalmoua has been appointed Alvotech’s Chief Operating Officer and Hafrun Fridriksdottir is stepping down following resubmission of the Biologics License Application (BLA) for AVT02, Alvotech’s proposed high-concentration interchangeable biosimilar to Humira® (adalimumab).

REYKJAVIK, Iceland, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first six months of 2023 and provided a summary of recent corporate highlights.

- Approval of Adalimumab-EVA™ represents the second biosimilar approval under the strategic partnership between Alvotech and Bioventure

REYKJAVIK, Iceland, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first six months of 2023, after U.S. markets close on Wednesday, August 30, 2023.

REYKJAVIK, Iceland, July 31, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement, in an overseas directed offering directed solely into Iceland to professional clients or eligible counterparties, of subordinated convertible bonds denominated in Icelandic krona (ISK) and US dollar (the “Bonds”) for a par value of $100 million. Alvotech expects to use the proceeds for continued development of its biosimilars pipeline.

TEL AVIV, Israel and PARSIPPANY, N.J. and REYKJAVIK, Iceland, July 24, 2023 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a global leader in generic and innovative medicines and Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that they have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.

REYKJAVIK, Iceland, June 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.

REYKJAVIK, Iceland and TEL AVIV, Israel and PARSIPPANY, N.J., June 12, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced they have reached a settlement and license agreement with Johnson & Johnson NYSE:JNJNYSEJNJ)

REYKJAVIK, Iceland, May 31, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 7, 2023. Alvotech will present and host investor and business meetings at the conference.

REYKJAVIK, Iceland and LONDON, May 24, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of five biosimilar candidates in Europe. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe.

REYKJAVIK, Iceland, May 19, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first three months of 2023 and provided a summary of recent corporate highlights.

REYKJAVIK, Iceland, May 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Morgan Stanley Annual Sustainable Finance Summit on May 22, 2023.

REYKJAVIK, Iceland, May 15, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the release of its second annual Equality Report covering 2022.

REYKJAVIK, Iceland, May 10, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into an exclusive agreement with Polifarma Ilac San. ve tic. A.S. (“Polifarma”) for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea® (aflibercept).

REYKJAVIK, Iceland, May 04, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech’s confirmatory patient study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The objective of the clinical study is to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.

REYKJAVIK, Iceland, May 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2023, after U.S. markets close on Thursday, May 18, 2023.

REYKJAVIK, Iceland, April 19, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to the company’s Quality unit. Sandra Casaca has been appointed Chief Quality Officer of Alvotech and Sarah Tanksley will be joining the Board of Directors of Alvotech hf., the operating entity for Alvotech’s manufacturing site in Iceland.

REYKJAVIK, Iceland, April 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA. Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.

REYKJAVIK, Iceland, March 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (Nasdaq: ALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced an update to the Company’s Corporate Sustainability framework, including the release of key environmental, social and governance (“ESG”) indicators for 2022.

REYKJAVIK, Iceland, March 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the presentation of two posters related to its clinical studies in support of biosimilarity and clinical comparability of Alvotech’s ATV04 (ustekinumab) and the reference product Stelara® at the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans.

REYKJAVIK, Iceland, March 01, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2022 and provided a summary of recent corporate highlights.