Biosimilar Development News

  1. Alvotech Further Strengthens Liquidity By Securing Term Loan Facility Of $75M 7/1/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has amended its existing credit agreement with funds managed by GoldenTree Asset Management LP and other existing lenders of Alvotech to provide a term loan facility of up to $75 million in additional capital.

  2. Harrow Announces Commercial Launch Of BYOOVIZ® In The United States 7/1/2026

    Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the commercial launch of BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab) and developed by Samsung Bioepis Co., Ltd.

  3. Orion Pharma Announces Agreement With Shilpa Medicare For Nivolumab Biosimilar For European Market 6/30/2026

    Orion Pharma (“Orion”) and Shilpa Biologicals Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited (“Shilpa”), have entered into an agreement to commercialise intravenous (iv) nivolumab biosimilar in Europe.

  4. EirGenix Showcases Dual-Track Biosimilars And CDMO Strategy In U.S. Market Push At BIO 2026 6/30/2026

    At BIO 2026, EirGenix presented its comprehensive HER2-positive breast cancer biosimilar portfolio and highlighted its integrated one-stop contract development and manufacturing organization (CDMO) service platform.

  5. Samsung Bioepis Announces Positive Preliminary Phase 1 And Phase 3 Data For SB27, A Proposed Biosimilar To Keytruda (Pembrolizumab) 6/29/2026

    Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to eytruda1 (pembrolizumab), have met their primary endpoints.

  6. New Study Examines Real-World Switching Patterns After Patients Transition From Humira To Biosimilars 6/29/2026

    Researchers from Truveta have found that adoption of adalimumab biosimilars increased substantially following formulary changes in the United States, though more than one in seven patients who switched from originator adalimumab (sold as Humira) later returned to the originator product.

  7. Henlius' Proposed Ipilimumab Biosimilar HLX13 Completes First Patient Dosing In The U.S., Advancing Global Multicenter Clinical Development 6/25/2026

    Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its independently developed investigational ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) has completed first patient dosing in the United States in its international multicenter phase 1 clinical study (HLX13-HCC102).

  8. Organon Canada And Henlius Expand Access To Denosumab Treatments With Launch Of BILDYOS (denosumab injection) And TUZEMTY (denosumab injection), Biosimilars To PROLIA And XGEVA 6/23/2026

    Organon Canada and Shanghai Henlius Biotech, Inc. (2696.HK) today announced that BILDYOS (denosumab injection) 60 mg/1 mL and TUZEMTY (denosumab injection) 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, are now available in Canada for all indications of reference products.

  9. Sandoz To Host Capital Markets Day: Maximising Sandoz Value In Its Golden Decade For Biosimilars 6/22/2026

    The formal part of the event, webcast live, will begin at 13:30. In-person attendance will be by invitation only on a first-come, first-served basis; invitations will be distributed in due course.

  10. Organon And Samsung Bioepis Expand Agreement To Commercialize PYZCHIVA (ustekinumab), A Biosimilar Referencing STELARA (ustekinumab) In Canada 6/18/2026

    Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA, Samsung Bioepis’s biosimilar referencing STELARA (ustekinumab).