Biosimilar Development News

  1. Health Canada Approves Biocon And Mylan’s Ogivri, The First Trastuzumab Biosimilar, For The Treatment Of HER2-Positive Breast And Gastric Cancers

    Biocon Ltd. and Mylan N.V. recently announced that Health Canada has approved Mylan’s Ogivri (trastuzumab), a biosimilar to Herceptin (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

  2. FDA Issues Draft Guidance For Industry On The Design And Evaluation Of Comparative Analytical Studies For Biosimilarity

    Recently, FDA released Draft Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations.

  3. NeuClone To Initiate Phase I Clinical Trial Of Stelara (Ustekinumab) Biosimilar, The Second Biosimilar From The 10-Product Portfolio With Serum Institute

    NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced it will initiate the Phase I clinical trial of its Stelara® (ustekinumab) biosimilar in the second half of 2019.

  4. Mylan And Biocon To Present Final Overall Survival Data For Ogivri™ (trastuzumab-dkst), A Biosimilar To Herceptin®, At The American Society Of Clinical Oncology (ASCO) Annual Meeting

    Mylan N.V.(NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

  5. AbbVie Resolves HUMIRA® (adalimumab) U.S. Patent Litigation With Boehringer Ingelheim

    AbbVie (NYSE: ABBV) announced that it has resolved U.S. HUMIRA (adalimumab) litigation with Boehringer Ingelheim (BI). Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States.

  6. Michel Mikhail Invites Biosimilar Experts To Attend SMi’s 10th Annual Biosimilars Conference

    Chairman of the 2019 Biosimilars Conference, Michel Mikhail, International Expert Regulatory Affairs, Global Expert of Biosimilars, invites biosimilar experts to attend the next Biosimilars Conference, taking place in London.

  7. Formycon Announces News On Development Portfolio

    For FYB201, a biosimilar candidate for Lucentis (ranibizumab), Formycon and Bioeq IP AG successfully concluded a Type IV Pre-Submission Meeting in December 2018 with the US Food and Drug Administration (FDA).

  8. Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes For New Products

    US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

  9. Statement From Acting FDA Commissioner Ned Sharpless, M.D., On Policy Advancements To Help Bring Interchangeable Biosimilars To Market

    The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.

  10. Coherus BioSciences Reports Corporate Highlights And First Quarter 2019 Financial Results

    Coherus BioSciences, Inc. (“Coherus” or “the Company”, Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended March 31, 2019.