Biosimilar Development News

  1. Alvotech Announces Positive Top-Line Results For Two Comparative Studies For AVT02, A Proposed Biosimilar To HUMIRA (adalimumab) 5/12/2020

    Alvotech today announce that two studies for AVT02 have met their primary objectives. AVT02 is being developed as a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms that is expected to be more convenient for patients and differentiating from most biosimilar competitors, while matching the newest dosage forms of the reference product.

  2. USP Launches Trust Accelerated Program To Help Speed Development Of Quality COVID-19 Treatments And Vaccines 5/11/2020

    To accelerate the development of safe and effective COVID-19 vaccines, medicines and other treatments, the U.S. Pharmacopeia (USP) has launched a new program to support scientists, developers and manufacturers worldwide.

  3. Infiniti’s Recent Article Explores Key Themes Shaping The Global Biosimilars Market 5/8/2020

    A well-known market intelligence company, Infiniti Research, has worked with 100+ companies in the biosimilars market across the globe. Our expertise in the field of market research enables us to offer tailored solutions that empower biosimilars market leaders to gauge how prepared and well-positioned they are for the future

  4. Bausch + Lomb Licenses Exclusive Rights From STADA And Xbrane To A Biosimilar Candidate For Lucentis (ranibizumab) In The United States And Canada 5/6/2020

    Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has entered into an exclusive licensing agreement with STADA Arzneimittel AG and its development partner, Xbrane Biopharma AB, a leading Nordic biosimilar developer, to develop and commercialize a biosimilar candidate to Lucentis (ranibizumab) in the United States and Canada.

  5. Teva And Celltrion Healthcare Announce The Launch Of TRUXIMA (rituximab-abbs) Injection For Rheumatoid Arthritis, The Only Biosimilar To Rituxan (rituximab) Available In The United States For This Indication 5/4/2020

    Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, Co., Ltd., today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of: Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies.

  6. Revance And Mylan Biosimilar To BOTOX Program Decision To Extend Beyond April 30, 2020 5/1/2020

    Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI), today announced that it is continuing discussions with Mylan N.V. regarding whether or not Mylan plans to move forward with the biosimilar to BOTOX program.

  7. Pharmaceutical Shipping Costs Spike In Response To Global COVID-19 Pandemic 4/30/2020

    The cost of shipping pharmaceuticals to the United States has risen sharply as a result of the global coronavirus pandemic, according to a new survey of generic drug manufacturers conducted by the Association for Accessible Medicines (AAM).

  8. AAM Releases Blueprint For Enhancing The Security Of The U.S. Pharmaceutical Supply Chain 4/30/2020

    The Association for Accessible Medicines today released “A Blueprint for Enhancing the Security of the U.S. Pharmaceutical Supply Chain,” a six-element framework that lays out concrete actions that the federal government could take to ensure that U.S. patients and the U.S. health care system have access to a secure and consistent supply of critical pharmaceuticals.

  9. Richter Entered Into An Asset Purchase Agreement With Mycenax For The Biosimilar Tocilizumab 4/29/2020

    ​Gedeon Richter Plc. ("Richter") today announced that it has entered into an asset purchase agreement with Mycenax Biotech Inc. ("Mycenax") in respect of biosimilar tocilizumab ("Product") for the treatment of rheumatoid arthritis.

  10. Biocon And Mylan Launch Fulphila, Biosimilar Pegfilgrastim, In Canada 4/28/2020

    Biocon Ltd. and Mylan N.V. today announced the launch of Fulphila, a biosimilar to Neulasta (pegfilgrastim). Fulphila is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.