Biosimilar Development News

31. Fresenius Expands Biosimilars Portfolio With The Launch Of Denosumab Biosimilars In The US 7/1/2025

    Fresenius announced today that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States.

32. Alvotech And Advanz Pharma Enter Into European Supply And Commercialization Agreement For Biosimilar Candidate To Cimzia® (certolizumab pegol) 7/1/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“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 a supply and commercialization agreement for AVT10, Alvotech’s biosimilar candidate to Cimzia® (certolizumab pegol).

33. Bio Usawa Biotechnology And Bioeq AG Partner To Create Widespread Access To Vision-Saving Medicine Across Sub-Saharan Africa 7/1/2025

    Bio Usawa Biotechnology Ltd. (Bio Usawa) and Bioeq AG today announced a groundbreaking agreement that will bring a life-changing biosimilar medicine—ranibizumab, used to treat serious retinal diseases—within reach for millions across Sub-Saharan Africa.

34. Sandoz Further Asserts Leadership In Biosimilars, Breaking Ground On New Slovenia Facility To Expand European Biosimilar Hub And Global Market Reach 7/1/2025

    Sandoz, the global leader in generic and biosimilar medicines, today announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia.

35. Biocon Biologics Receives Health Canada Approval For Yesafili™ (aflibercept); First Global Launch Scheduled For July 2025 6/27/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Yesafili™ (aflibercept), a biosimilar to Eylea® (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL on June 26, 2025.

36. Kashiv BioSciences Announces Positive Topline Results From Confirmatory Efficacy Study Of ADL-018, Biosimilar Candidate To XOLAIR (omalizumab) 6/25/2025

    Kashiv BioSciences, LLC today announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR (omalizumab).

37. Bio-Thera Solutions And SteinCares Expand Partnership To Commercialize Biosimilars For Treatment Of Inflammatory Diseases Across Latin America 6/25/2025

    Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and SteinCares, a leading specialty healthcare company in Latin America, today announced the signing of a new agreement to commercialize a proposed biosimilar of dupilumab across Latin America.

38. Amneal Highlights Positive Topline Results From Confirmatory Clinical Study Of Biosimilar Candidate To XOLAIR® (omalizumab), Developed By Kashiv BioSciences 6/25/2025

    Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC.

39. Positive Top Line Results From Confirmatory Efficacy Study For Proposed Biosimilar To Xolair® (omalizumab) 6/25/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

40. Biocon Biologics Collaborates With National Cancer Society Malaysia 6/24/2025

    Biocon Biologics Limited, a fully integrated global biosimilars company, has partnered with the National Cancer Society of Malaysia (NCSM), a prominent not-for-profit cancer organization, to launch a Patient Assistance Program (PAP) in Malaysia aimed at improving access to affordable, high-quality biosimilars for underserved cancer patients in Malaysia.