Biosimilar Development News
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STADA And Alvotech Secure Approval For Uzpruvo, Europe’s First ustekinumab Biosimilar To Stelara
1/10/2024
Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab).
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Accord BioPharma, Inc. Announces U.S. FDA Acceptance Of Biologics License Application For Proposed STELARA® Biosimilar DMB-3115
1/4/2024
Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115.
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CVS Caremark Accelerates Biosimilars Adoption Through Formulary Changes
1/3/2024
Today CVS Caremark®, a CVS Health® (NYSE: CVS) company, announced the continuation of its efforts to expand adoption of biosimilars. Effective April 1, 2024, Humira® will be removed from our major national commercial template formularies and Humira biosimilars will be covered.
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Glenmark Is The First To Launch Biosimilar Of Popular Anti-Diabetic Drug, Liraglutide, In India
1/3/2024
Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, global pharmaceutical company, has launched a biosimilar of the popular10,11 anti-diabetic drug, Liraglutide, for the first time in India.
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Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence Between Biosimilar Candidate AVT06 And Reference Product Eylea® (aflibercept)
1/3/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept).
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Formycon Announces EMA Acceptance Of The MAA For FYB203, A Biosimilar Candidate To Eylea (Aflibercept)
12/27/2023
Formycon AG and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea1 (Active Ingredient: Aflibercept), for review.
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Coherus Announces FDA Approval Of UDENYCA ONBODY™, A Novel And Proprietary State-Of-The-Art Delivery System For pegfilgrastim-cbqv
12/26/2023
Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
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Xbrane Biopharma Registers Three New Patents In Sweden
12/22/2023
Xbrane Biopharma AB (publ) ("Xbrane") announced today that the company has been granted three new patents during December from the Swedish Intellectual Property Office (PRV). All patents protect genes that express antibody models.
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Biocon Biologics Partners With Sandoz For The Distribution Of ‘Adalimumab BS Subcutaneous Injection [FKB]’ In Japan
12/22/2023
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, signed today a Distribution Agreement with Sandoz, granting the Company the exclusive rights to promote, sell and distribute “Adalimumab BS for subcutaneous injection [FKB]”*1 in Japan.
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Intas Pharmaceuticals Ltd. Announces Licensing Agreement With mAbxience, For An Etanercept Biosimilar Targeting Autoimmune Diseases In More Than 150 Countries, Including Europe And The United States Of America
12/20/2023
Intas Pharmaceuticals Ltd., a leading multinational pharmaceutical company, has announced today a strategic exclusive licensing agreement with mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for a biosimilar for Etanercept.