Biosimilar Development News

  1. Samsung Bioepis Presents Phase 1 Study Results Of SB17 (Ustekinumab), A Proposed Biosimilar To Stelara, At 2023 AAD Annual Meeting 3/17/2023

    Samsung Bioepis Co., Ltd. today announced that SB17, a proposed biosimilar to Stelara1 (ustekinumab), demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in Phase 1 clinical study with healthy volunteers.

  2. Stevanato Group Collaborates With Recipharm To Develop And Manufacture Pre-Fillable Syringes For Use In A New Soft Mist Inhaler For The Inhalation Of Sensitive Biological Products 3/16/2023

    The new strategic collaboration aims to provide innovative primary packaging to pharmaceutical and biopharmaceutical companies using Recipharm’s proprietary soft mist inhalers.

  3. Sandoz Signs Memorandum Of Understanding To Build New Biologics Production Plant In Slovenia, To Support Increasing Global Demand For Biosimilar Medicines 3/9/2023

    Sandoz, a global leader in generic and biosimilar medicines, today signed a Memorandum of Understanding (MOU) to build a new biologics production plant in Lendava, Slovenia.

  4. Biosimilars Canada Announces Board Chair And Vice-Chair 3/9/2023

    Biosimilars Canada is pleased to announce the unanimous election of Mr. Mike Woolcock, Senior Vice President of the Apobiologix division of Apotex, as Chair of the Biosimilars Canada Board.

  5. Global Rituximab Biosimilars Market Report 2023: Major Players Include Pfizer, Mylan, Amgen, Teva Pharmaceutical Industries And Celltrion Healthcare 3/7/2023

    The "Rituximab Biosimilars Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.

  6. Biosimilars Key To Lowering Drug Prices; National Alliance Of Healthcare Purchaser Coalitions Releases Playbook To Help Employers Adopt 3/7/2023

    Broader acceptance and use of biosimilars – lower-cost versions of patented and branded drugs – by employers and other healthcare purchasers are key to preserving economic competition in the marketplace.

  7. FDA Approves UDENYCA® Autoinjector 3/6/2023

    Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

  8. Participants Dosed On Adessia In Germany In A Phase 1 Trial, A First For An Adalimumab Biosimilar Candidate Developed In Africa 3/6/2023

    MiGenTra, a Berlin-based healthcare transforming company, reported today that the first participants in a Phase 1 clinical trial for Minapharm Pharmaceuticals adalimumab biosimilar candidate (brand name: Adessia) were dosed on February 24, 2023 in Germany.

  9. Biosimilars Forum Applauds Congressman Hudson For Supporting Biosimilars Through Shared Savings Legislation 3/3/2023

    Juliana M. Reed, executive director the Biosimilars Forum, released the following statement after Congressman Richard Hudson (R-NC) introduced legislation to establish a shared savings reimbursement model for biosimilars in Medicare Part B.

  10. FDA And FTC Collaborate To Advance Competition In The Biologic Marketplace 3/2/2023

    The U.S. Food and Drug Administration regulates biological products, or biologics, which have transformed the treatment of many illnesses and are the fastest-growing class of medications in the U.S. Biologics offer hope and healing to millions of Americans, but they can be expensive.