Biosimilar Development News

1. Formycon Announces Positive Clinical Data For Keytruda Biosimilar Candidate FYB206 (pembrolizumab) 2/25/2026

   Formycon AG announces that the primary endpoint of the pivotal Dahlia pharmacokinetics study (PK study) has been met.

2. SteinCares And Shilpa Biologicals Strike Into Licensing Agreement To Expand Access To Biosimilars Across Latin America 2/25/2026

   SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL), a fully integrated biopharmaceutical subsidiary of Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), announce a strategic licensing agreement to commercialize a biosimilar across Latin America.

3. Sandoz Confirms European Commission Approval For Ranluspec (ranibizumab), Further Strengthening Overall Biosimilars Leadership And Position In Ophthalmology 2/23/2026

   Sandoz, the global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ranluspec¹. 

4. Lupin Receives European Commission Approval For Biosimilar Ranibizumab 2/23/2026

   Global pharma major Lupin Limited (Lupin) today announced that it has received the approval from European Commission for its biosimilar ranibizumab, Ranluspec (for vials and pre-filled syringes), following the recent positive opinion from the Committee for Medicinal Products for Human Use.

5. Dr. Reddy's Announces USFDA Acceptance To Review Its Biologics License Application (BLA) For Proposed Interchangeable Biosimilar, Abatacept 2/20/2026

   Dr. Reddy’s Laboratories Ltd., today announced that the US Food and Drug Administration (USFDA) has accepted for review, its 351 (k) Biologics License Application (BLA) IV for infusion formulation for DRL_AB, a proposed interchangeable biosimilar to ORENCIA (abatacept) that was submitted in December 2025.

6. Zydus Launches Biosimilar Aflibercept 2 mg ANYRA For Advancing Ophthalmic Care 2/19/2026

   Zydus Lifesciences Ltd., an innovation-led global life sciences company, today announced the launch of Anyra, India’s first indigenously developed biosimilar of Aflibercept 2 mg. Zydus has also signed an agreement with Regeneron Pharmaceuticals, Inc. and Bayer.

7. Sandoz Receives US FDA Approval To Expand Enzeevu (aflibercept-abzv) Label For Multiple Retinal Indications 2/18/2026

   Sandoz , the global leader in affordable medicines, today announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu (aflibercept-abzv), to include multiple retinal indications.

8. FDA Approves FILKRI7™ (filgrastim-laha), Accord BioPharma's Biosimilar To NEUPOGEN® (filgrastim) 2/17/2026

   Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved FILKRI™ (filgrastim-laha), a biosimilar to NEUPOGEN® (filgrastim), for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).1

9. U.S. FDA Clears IND For Phase 1 Study Of Henlius' Subcutaneous Daratumumab Biosimilar 2/16/2026

   Shanghai Henlius Biotech, Inc. today announced that the Investigational New Drug (IND) application for HLX15-SC, the subcutaneous formulation of HLX15, the Company’s daratumumab biosimilar candidate (recombinant anti-CD38 fully human monoclonal antibody), has been cleared by the U.S. Food and Drug Administration (FDA). The study is intended for first-line treatment of multiple myeloma.

10. STADA And Bio-Thera Receive European Marketing Authorization For Gotenfia, A Biosimilar To Simponi 2/13/2026

    Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, have received a marketing authorization from the European Commission[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®.