Biosimilar Development News

1. FDA Grants Interchangeable Designation To Fresenius Kabi's Biosimilar Otulfi (ustekinumab-aauz) 5/19/2025

   Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara (ustekinumab).

2. First Subject Dosed For Phase 1/3 Clinical Trial Of Henlius' Proposed Ipilimumab Biosimilar 5/16/2025

   Shanghai Henlius Biotech, Inc. announced that the first subject was dosed for a phase 1/3 clinical trial of the company's independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in China.

3. The Biosimilars Forum Submits Comments Highlighting Biosimilars As Safe And Effective Lower-Cost Medicines For Americans That Need Them 5/13/2025

   Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the submission of the Biosimilars Forum’s comments to the Department of Commerce regarding their ongoing Section 232 investigation into the national security impact of imports of pharmaceuticals and pharmaceutical ingredients.

4. Biosimilars Forum Applauds House Of Representatives Committee On Energy And Commerce For Including PBM Reform In Reconciliation Package 5/13/2025

   “Biosimilars Forum applauds the House of Representatives Committee on Energy and Commerce for including PBM reform in its first draft of the reconciliation package. Reforming the PBM Monopoly is critical to lowering prescription drug prices for Americans and providing more lower-cost drug options, like biosimilars.

5. ProBioGen Enters Agreement With Polpharma Biologics To Provide High-Performance Cell Line Development Services 5/7/2025

   ProBioGen announced today an agreement with Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars. Under this agreement ProBioGen will conduct high-performance cell line development services for Polpharma's biosimilar candidate, supporting their expanding pipeline.

6. Biocon Biologics Secures Strong Market Access Coverage For Yesintek™ In The United States Covering 100+ Million Lives 5/5/2025

   Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced the Company has secured multiple market access agreements for Yesintek™ (ustekinumab-kfce), its biosimilar to Stelara® (ustekinumab).

7. Teva And Alvotech Announce FDA Approval Of Interchangeability For SELARSDI™ (ustekinumab-aekn) With Stelara® (ustekinumab) 5/5/2025

   Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab).

8. Henlius Enters Into License Agreement With Sandoz For Proposed Ipilimumab Biosimilar 4/29/2025

   On April 29, 2025, Shanghai Henlius Biotech, Inc. announced a licensing agreement with Sandoz, the global leader in generic and biosimilar medicines, granting exclusive commercialization rights for its self-developed ipilimumab biosimilar HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

9. Bone Health: Biocon Biologics Receives Positive CHMP Opinions For Biosimilar Denosumab In Europe 4/29/2025

   Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523) (NSE: BIOCON), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the authorization of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo® and Denosumab BBL (brand name is currently under approval).

10. CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code For Otulfi (ustekinumab-aauz) 4/28/2025

    Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code for Otulfi (ustekinumab-aauz).