Biosimilar Development News

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. Vizient Expresses Concern With FDA Policy On Naming Of Biologic Medications

    Vizient, Inc. recently submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.

  7. Two Clinical Studies With IBI301, A Biosimilar Candidate To Rituximab, Met Primary Endpoints

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announced today that IBI301, a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody being co-developed as a potential biosimilar to rituximab, which is sold under the brand name MabThera/Rituxan has met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, namely: a phase III clinical trial (CIBI301A301) in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study (CIBI301A201) in patients with CD20-positive B-cell lymphoma. The details of these studies will be disclosed in future publications in scientific journals and conferences.

  8. ‘Biosimilars & Breast Cancer’ White Paper Shares Recommendations From Physicians And Patients On The Use And Implementation Of Biosimilars In Oncology

    Biologic treatments have been approved and used in Canada for several decades, marking the beginning of an exciting time for the treatment of many diseases as these therapies truly changed the outcomes for many patients living with chronic and often fatal diseases.

  9. Fresenius Kabi launches Biosimilar Adalimumab IDACIO In Germany

    Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announces recently that the company is launching its first biosimilar medicine in Germany. IDACIO is available in the following administration options: pre-filled syringe, pre-filled pen and the vial presentation.

  10. Coherus BioSciences And Amgen Settle Trade Secrets Action

    Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that Amgen and Coherus have settled the trade secret action brought by Amgen against Coherus that was pending in the Superior Court of California County of Ventura.