Biosimilar Development News

  1. Bio-Thera Solutions Partners With Tabuk Pharmaceuticals To Commercialize BAT2206, A Stelara® (ustekinumab) Biosimilar In Saudi Arabia 12/24/2024

    Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia.

  2. CuraTeQ Biologics Receives UK MHRA Approval For Bevqolva (Bevacizumab Biosimilar) 12/21/2024

    Drug maker Aurobindo Pharma Ltd on Saturday (December 21) said its step-down subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva, its biosimilar version of bevacizumab.

  3. Fresenius To Expand Biopharma Portfolio With A New Licensing Agreement To Commercialize A Proposed Aflibercept Biosimilar 12/20/2024

    Under the agreement, Fresenius Kabi will commercialize the proposed aflibercept biosimilar, a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein, in the US, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico after successful approval by respective health agencies.

  4. AAM Applauds Senate Bill To Protect Patient Access To Affordable Medicines 12/19/2024

    Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars.

  5. Glyconex Announces First Patient Dosed In Phase 3 Clinical Trial For Denosumab Biosimilar 12/17/2024

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that the first patient has been dosed in the Phase 3 clinical trial of its denosumab biosimilar, SPD8.

  6. U.S. FDA Approves Celltrion's STEQEYMA® (ustekinumab-stba), A Biosimilar To STELARA® (ustekinumab) 12/17/2024

    Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.[1]

  7. Bio-Thera Solutions Expands Partnership With SteinCares In LATAM With Addition Of A Third Biosimilar To Partnership 12/16/2024

    Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars today announced an expansion of their partnership with SteinCares today with the addition of a third biosimilar to the partnership.

  8. Biosimilars Forum Welcomes Henlius As Newest Member 12/12/2024

    The Biosimilars Forum has announced Henlius (2696.HK), a global biopharmaceutical company, as its newest member.

  9. ASBM Responds To PCMA: Put Patients First, Not PBM Profits 12/9/2024

    As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust.

  10. Latest Results Of 5 Clinical Trials Released At ESMO Asia 2024 12/9/2024

    Recently, results from five clinical trials of Henlius' self-developed products, including novel anti-PD-1 mAb HANSIZHUANG (serplulimab), anti-EGFR mAb HLX07 and daratumumab biosimilar candidate HLX15, were released at European Society for Medical Oncology Asia (ESMO Asia) Congress 2024.