Biosimilar Development News

1. 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.

2. 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.

3. 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).

4. AAM Applauds Momentum As Two Bills Move Through Senate HELP Committee 6/17/2026

   Today, alongside its Biosimilars Council, the Association for Accessible Medicines applauds the positive momentum for America’s patients, as the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act both pass out of the Senate HELP Committee.

5. Sandoz Steps Up In-House Biosimilar Capabilities, Opening State-Of-The-Art Development Centre To Capture 'Golden Decade' Opportunity 6/17/2026

   Sandoz, the global leader in affordable medicines, today inaugurates a new biosimilar development centre in Ljubljana,

6. Alvotech Announces FDA Acceptance Of Biologics License Application For AVT16, A Proposed Interchangeable Biosimilar To Entyvio® 6/16/2026

   Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

7. Xbrane Biopharma AB And JOINN Biologics US Inc. Enter Strategic Partnership To Develop Xdarzane – Xbrane´s Biosimilar Candidate To Darzalex (Daratumumab) 6/11/2026

   Xbrane Biopharma AB (“Xbrane”), a Sweden-based biotechnology company focused on the development of biosimilars, and JOINN Biologics US Inc. (“JOINN”), a US-based leading biologics development and manufacturing organization, today announced that the companies have entered into a strategic partnership featuring customized development services for Xdarzane, Xbrane´s biosimilar candidate referencing Darzalex (daratumumab).

8. Abbott Receives Approval For Two New Biosimilars In Brazil, Expanding Access To Treatment For Osteoporosis And Bone Complications Related To Cancer 6/11/2026

   Abbott (NYSE: ABT), a global leader in healthcare, has just received regulatory approval from Anvisa (Brazilian Health Regulatory Agency) for two new denosumab biosimilar medications in Brazil (60 mg and 120 mg), representing another significant step in expanding access to advanced therapies for osteoporosis and cancer-related bone complications.

9. Organon Secures US Food And Drug Administration Approval Expanding Indications For TOFIDENCE (tocilizumab-bavi) In Cytokine Release Syndrome (CRS) And Pediatric COVID-19 6/10/2026

   Organon today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab).

10. GlycoNex Announces Positive Topline Results For Phase III Clinical Trial Of Denosumab Biosimilar SPD8 6/10/2026

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, has successfully met its primary endpoint.