Biosimilar Development News

  1. The Biosimilars Forum Applauds HHS Proposal To Target Costly Rebates Structure Blocking Patients From Biosimilars And Savings
    1/31/2019

    The Biosimilars Forum applauded today’s proposed HHS rule attacking negotiated rebates between manufacturers and insurers.

  2. Routine Mass Analysis Enables Greater Productivity In Biopharma Development
    1/30/2019

    Recently, a large biopharma company was forced to pay a $100M fee to their partner after halting commercialization of a biosimilar. Three years after they started the commercialization project, the company cited the cost of manufacturing the drug as too high and its projected selling price too low to justify bringing it to market.

  3. PCMA Offers Policy Solutions To Reduce Prescription Drug Costs
    1/28/2019

    As Congress begins to examine high prescription drug prices, the Pharmaceutical Care Management Association (PCMA) sent letters to several congressional committees highlighting the value pharmacy benefit managers (PBMs) provide to patients and payers as well as outlining policy options to reduce prescription drug costs.

  4. NMPA Accepts New Drug Application For IBI-305, A Biosimilar Product Candidate Of Bevacizumab (Avastin®)
    1/28/2019

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, announced today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for a biosimilar product candidate of bevacizumab (Avastin®).

  5. Coherus BioSciences Announces Filing Of Patent Infringement Suit Against Amgen Directed To Amgen’s Humira Biosimilar Formulation
    1/25/2019

    Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, today announced it has filed suit against Amgen in the United States District Court (Delaware) alleging that Amgen’s Humira® biosimilar, Amgevita™, infringes Coherus’ U.S. patents 10,155,039; 10,159,732; and 10,159,733. Each of the asserted Coherus patents is directed to stable formulations of adalimumab.

  6. Coherus BioSciences Announces Global Settlement With AbbVie Securing Rights To Commercialize Its Adalimumab Biosimilar Candidate, CHS-1420
    1/25/2019

    Coherus BioSciences, Inc.(Nasdaq: CHRS), a commercial biosimilar company, today announced it has executed settlement agreements with AbbVie Inc. that grant Coherus global, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab (HUMIRA®) biosimilar.

  7. Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab
    1/24/2019

    Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis.

  8. Bio-Thera Solutions Announces Initiation Of Phase III Clinical Trial For BAT1806, A Proposed Biosimilar Of Actemra (Tocilizumab)
    1/22/2019

    Bio-Thera Solutions, a clinical-stage pharmaceutical company, recently announced that dosing has begun in a Phase III clinical study for its tocilizumab biosimilar, BAT1806. Bio-Thera’s Phase III clinical trial will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s RoActemra in patients with rheumatoid arthritis (RA).

  9. Alvotech Completes U.S. $300M Financing Deal
    1/22/2019

    Alvotech announced recently that it has successfully raised US$300M through a private bond offering. Net proceeds from the capital raised will be used to fuel continued growth, refinance of existing debt and the further development of Alvotech’s biosimilar assets.

  10. The Center For Biosimilars Talks With Michael Kolodziej, M.D., About How Payers Are Preparing For Biosimilars
    1/21/2019

    The Center for Biosimilars, an online resource for emerging therapies that focuses on improving patient outcomes, interviewed Michael Kolodziej, M.D., vice president and chief innovation officer at ADVI Health Inc., about what payers will consider when developing strategies around biosimilars.