Biosimilar Development News

1. Waltz Health And Fresenius Kabi Expand Direct Access To Biosimilars Through Waltz Connect Platform 10/29/2026

   Waltz Health®, an EVERSANA® company developing technologies and services that support better-informed decisions on prescription care and Fresenius Kabi®, an operating company of Fresenius, and a leading provider of essential medicines and medical technologies, today announced an agreement to provide employers, payers and pharmacy benefit managers (PBMs) with direct access to three competitively priced biosimilars.

2. BioSim Proposes Incorporating Measures Into Electoral Programs To Promote Biosimilar Medicines 10/26/2026

   Ahead of the November 29th elections, the Spanish Association of Biosimilar Medicines (BioSim) is presenting political parties with a proposal of measures for inclusion in their electoral programs for the next legislature.

3. Bio-Thera Announces NMPA Approval Of BAT2306, The First Secukinumab Biosimilar Approved In China 10/26/2026

   Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, today announced that the National Medical Products Administration (NMPA) has approved its marketing authorization for BAT2306, a secukinumab biosimilar.

4. Samsung Bioepis Releases Fourth Quarter 2026 Biosimilar Market Report Highlighting Importance Of Supply Continuity 10/22/2026

   Samsung Bioepis Co., Ltd. today released its Fourth Quarter 2026 Biosimilar Market Report, marking the fifteenth edition of the Quarterly Biosimilar Market Report in the United States (US).

5. Celltrion Healthcare Canada Ltd. Announces The Opening Of A New Office In Montreal, Strengthening Its Growing Presence In Quebec 10/22/2026

   Celltrion, a South Korean biopharmaceutical company recognized globally for the development and commercialization of innovative biologics and biosimilars, today announced the official opening of its new office in Montreal.

6. Formycon And Biocelys Combine Complementary Development And Manufacturing Expertise In New Biosimilar Project FYB286 10/21/2026

   Formycon AG (FSE: FYB, Prime Standard, “Formycon“) and Biocelys S.A. (“Biocelys”), a company of the ATHOS Group, today announced the launch of a collaboration to develop the biosimilar candidate FYB286.

7. Samsung Bioepis Enters Into Landmark 10-Year Agreement To Supply Eculizumab To The Brazilian Market, Anchoring Long-Term Growth In Latin America 10/20/2026

   Samsung Bioepis Co., Ltd. today announced a landmark 10-year agreement with its local partners in Brazil—state-level public laboratory Bahiafarma and local pharmaceutical leader Bionovis—to supply its eculizumab biosimilar, SB12, to Brazil’s universal public health system, the Sistema Único de Saúde (SUS).

8. Alvotech Receives FDA Approval For New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch 10/20/2026

   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 approved a new manufacturing process for SIMLANDI® (adalimumab-ryvk), Alvotech’s biosimilar to Humira® (adalimumab).

9. Samsung Bioepis To Present Clinical And Scientific Data For Oncology Biosimilars At ESMO Congress 2026 10/19/2026

   Samsung Bioepis Co., Ltd. today announced that it will present clinical and scientific data for its two oncology biosimilars—SB27, a proposed biosimilar to Keytrudaⁱ (pembrolizumab), and SB16ⁱⁱ, a biosimilar to Proliaⁱⁱⁱ/Xgeva^iv (denosumab)— at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain.

10. Generic Medicines Manufacturers Ramp Up Patch Supply To Meet Demand 10/14/2026

    The Association for Accessible Medicines and the Biosimilars Council today highlighted the key role generic medicines manufacturers, led by several AAM member companies, are playing in ramping up the supply of estrogen patches as demand has dramatically increased.