Biosimilar Development News
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Fresenius Kabi lLaunches Tyenne7®*, The First And Only Approved tocilizumab Biosimilar In Canada
10/18/2024
Fresenius Kabi today launches its tocilizumab biosimilar Tyenne® referencing Actemra®** (tocilizumab) in Canada. Tyenne® is the first and only tocilizumab biosimilar currently available in Canada.
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Henlius Shines At CPHI Worldwide 2024, Expanding New Opportunities For International Collaboration
10/14/2024
From October 8 to 10, the CPHI Worldwide 2024 was held at Fiera Milano in Italy. With the theme of "The Partner of Choice", Henlius showcased 6 launched products, its robust biologic pipeline and integrated global biopharmaceutical platform. Henlius drew a large crowd at the booth, and concluded the conference with over 250 meetings.
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US FDA Approves Dong-A ST's IMULDOSA (ustekinumab-srlf), A Biosimilar To STELARA
10/11/2024
Dong-A ST announced on October 11 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won U.S. Food and Drug Administration (FDA) approval.
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EMA Accepts Marketing Authorization Applications For AVT03, A Proposed Denosumab Biosimilar
10/10/2024
STADA today announced that the European Medicines Agency (EMA) has accepted for review marketing authorization applications for AVT03, a proposed biosimilar candidate to Prolia and Xgeva(denosumab) bone-health and oncology medicines.
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European Medicines Agency Confirms Acceptance Of Marketing Application For AVT03, A Proposed Biosimilar To Prolia® And Xgeva®
10/10/2024
Alvotech (NASDAQ: ALVO), 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).
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Bio-Thera And Richter Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, For EU countries, UK, Switzerland And Other Selected Countries
10/9/2024
Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Gedeon Richter ("Richter") announce today they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Stelara® (ustekinumab).
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Biocon Biologics' Commissioned Report Highlights Pathways To Increase Adoption Of Biosimilars In LMICs
10/8/2024
Biocon Biologics Limited, a fully integrated global biosimilars company, has published the results of a detailed study that provides key insights into creating a more supportive environment for biosimilars in low- and middle-income countries (LMICs), aimed at boosting uptake and expanding access to affordable healthcare solutions.
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Teva Prolia® (Denosumab) Biosimilar Candidate Is Accepted For Review By U.S. FDA And EU EMA
10/8/2024
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab)
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Prime Therapeutics Announces New, Cost-Effective Humira® Biosimilar Solutions, Offering Clients Flexibility And Choice
10/7/2024
Prime Therapeutics LLC (Prime) today announced new, cost-effective Humira biosimilar solutions, offering clients continued flexibility and choice, along with financial risk mitigation strategies designed to maintain and promote access to biosimilars for millions of Americans.
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Teva And mAbxience Expand Strategic Partnership To Include An Additional Oncology Biosimilar Candidate
10/3/2024
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate.