Biosimilar Development News

  1. European Medicines Agency Confirms Acceptance Of Marketing Application For AVT03, A Proposed Biosimilar To Prolia® And Xgeva® 10/10/2024

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).

  2. Bio-Thera And Richter Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, For EU countries, UK, Switzerland And Other Selected Countries 10/9/2024

    Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Gedeon Richter ("Richter") announce today they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Stelara® (ustekinumab).

  3. Biocon Biologics' Commissioned Report Highlights Pathways To Increase Adoption Of Biosimilars In LMICs 10/8/2024

    Biocon Biologics Limited, a fully integrated global biosimilars company, has published the results of a detailed study that provides key insights into creating a more supportive environment for biosimilars in low- and middle-income countries (LMICs), aimed at boosting uptake and expanding access to affordable healthcare solutions.

  4. Teva Prolia® (Denosumab) Biosimilar Candidate Is Accepted For Review By U.S. FDA And EU EMA 10/8/2024

    Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab)

  5. Prime Therapeutics Announces New, Cost-Effective Humira® Biosimilar Solutions, Offering Clients Flexibility And Choice 10/7/2024

    Prime Therapeutics LLC (Prime) today announced new, cost-effective Humira biosimilar solutions, offering clients continued flexibility and choice, along with financial risk mitigation strategies designed to maintain and promote access to biosimilars for millions of Americans.

  6. Teva And mAbxience Expand Strategic Partnership To Include An Additional Oncology Biosimilar Candidate 10/3/2024

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate.

  7. Blue Shield Of California Slashes Cost Of World's Best-Selling Drug 10/1/2024

    Blue Shield of California today announced it has drastically cut the price it will pay for an FDA-approved biosimilar of blockbuster drug Humira – purchasing the medicine at a transparent net price of $525 per monthly dose, compared to the market reported net price of Humira at $2,100.

  8. Evio Announces Groundbreaking Direct Purchase Agreement For Adalimumab Biosimilar 10/1/2024

    Evio Pharmacy Solutions, a Blues-founded company focused on transformational solutions in the high-cost medication space, today announced the successful negotiation and implementation of an innovative direct purchase agreement with Fresenius Kabi, an operating company of Fresenius, for Adalimumab-aacf — a lower priced biosimilar version of Humira.

  9. Fresenius Kabi And Formycon Receive U.S. FDA Approval For Biosimilar Otulfi* (ustekinumab-aauz) 9/30/2024

    Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab).

  10. AEON Biopharma Announces Positive Outcome From FDA Biosimilar Advisory Meeting 9/30/2024

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product.