Biosimilar Development News

31. African Development Bank Approves EUR 15 Million Loan To Boost Biosimilars' Development And Production In Egypt 3/26/2025

    The Board of Directors of the African Development Bank (the “AfDB”) has approved a EUR 15 million senior corporate loan to Minapharm Pharmaceuticals S.A.E. (Minapharm), a leading biopharmaceutical company in Egypt.

32. Biosimilars Forum Chair Of Scientific Affairs Committee To Speak At The Festival Of Biologics USA 3/24/2025

    Hillel P. Cohen, Chair of the Scientific Affairs Committee for the Biosimilars Forum, will speak at the Festival of Biologics USA 2025 on April 24, 2025, to discuss importance of streamlining biosimilar development.

33. Pfizer's IXIFI Will Be Available In Canada As Of April 1, 2025 3/21/2025

    Pfizer Canada is pleased to announce that IXIFI (infliximab for injection) will be available in Canada as of April 1. IXIFI is a biosimilar to Remicade (infliximab.) IXIFI was approved by Health Canada in December 2021 for all eligible indications of the reference product, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease (in adults and pediatric patients 9 years and older), fistulising Crohn’s disease, ulcerative colitis (in adults and pediatric patients 6 years and older), psoriatic arthritis, and plaque psoriasis.

34. Alvotech Acquires Xbrane's R&D Operations In Sweden And Further Affirms Its Global Leadership Position In Biosimilars Development And Production 3/20/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector.

35. Xbrane Has Entered Into An Agreement To Sell XB003 (Cimzia Biosimilar Candidate) And Parts Of Its Organization To Alvotech For A Total Consideration Of SEK 275 Million 3/20/2025

    Xbrane Biopharma AB (publ) ("Xbrane" or the "Company") has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million.

36. Alvotech And Dr. Reddy's Announce FDA Acceptance Of Biologic License Application For AVT03, A Proposed Biosimilar To Prolia And Xgeva 3/18/2025

    Dr. Reddy’s Laboratories Ltd. and Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab).

37. Lumicera Secures Purchase Agreement For Stelara Biosimilar, Delivering Major Cost Savings 3/13/2025

    Lumicera Health Services announced today it has secured a purchase agreement with Anda, Inc., an independent wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., for a lower-priced biosimilar version of Stelara (ustekinumab).

38. STEQEYMA® (ustekinumab-stba), A Biosimilar To STELARA® (ustekinumab), Now Available In The United States 3/12/2025

    Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024.

39. Celltrion's Infliximab, The First Monoclonal Antibody Biosimilar, Is Now Remdantry™ In Canada 3/11/2025

    Celltrion, Inc., a leading global biopharmaceutical company, announced today that its infliximab biosimilar will be marketed in Canada under the new brand name Remdantry starting April 1, 2025, following approval of the product name change by Health Canada.

40. U.S. FDA Approves Celltrion's OMLYCLO® (omalizumab-igec) As The First And Only Biosimilar With Interchangeability Designation Referencing XOLAIR® 3/9/2025

    Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).