Biosimilar Development News

  1. Polpharma Biologics Announces First-Of-A-Kind Multiple Sclerosis Biosimilar Natalizumab Receives Positive CHMP Opinion 7/24/2023

    Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab - a first-of-a-kind biosimilar for the treatment of multiple sclerosis.

  2. Sandoz Announces Plans To Build New Technical Development Center In Slovenia 7/20/2023

    Sandoz, a global leader in generic and biosimilar medicines, today announced an investment of approximately USD 90 million at its site in Ljubljana, Slovenia to establish a dedicated Sandoz Biopharma Development Center by 2026.

  3. EMA Accepts MAA For DMB-3115 Of Dong-A ST, A Stelara Biosimilar 7/17/2023

    Dong-A ST (President/CEO Min-young Kim) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (Ustekinumab). 

  4. European Medicine Agency Accepts Intas' Marketing Authorization Application For DMB-3115, A Proposed Biosimilar To Stelara® (Ustekinumab) 7/14/2023

    Intas Pharmaceuticals Ltd. announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).

  5. Coherus And Superior Biologics Announce National Distribution Agreement For YUSIMRY™ 7/13/2023

    Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and specialty pharmacy Superior Biologics, Inc. (“Superior Biologics”) today announced a national distribution agreement for YUSIMRY™ (adalimumab-aqvh) at a price of $995 per carton of two autoinjectors, a discount of more than 85% compared to Humira® (adalimumab), currently priced at $6,922 per carton of two pens.

  6. Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted For Review By USFDA, EMA And MHRA 7/12/2023

    Dr. Reddy’s Laboratories Ltd. hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).

  7. Fresenius Kabi’s Denosumab Biosimilar Candidate FKS518 Shows Positive Clinical Trial Results 7/12/2023

    Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that its denosumab biosimilar candidate FKS518 successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity.

  8. Samsung Bioepis Releases Its Second US Biosimilar Market Report 7/11/2023

    Samsung Bioepis Co., Ltd. today released the second edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the United States.

  9. Biosimilars Forum Congratulates Fresenius Kabi For Launch Of IDACIO 7/10/2023

    Juliana M. Reed, executive director the Biosimilars Forum, released the following statement expressing appreciation for Fresenius Kabi for launching IDACIO (adalimumab-aacf).

  10. Express Scripts Adds Three Biosimilars To Largest Formulary To Promote Competition And Advance Affordability, Choices For Patients 7/10/2023

    Express Scripts, the pharmacy benefits management (PBM) business of The Cigna Group's (NYSE: CI) Evernorth, announced today that as part of its commitment to driving greater affordability for clients and people living with inflammatory conditions, it will add three additional biosimilars to its National Preferred Formulary (NPF).