Biosimilar Development News

  1. AbbVie Receives CHMP Positive Opinion For HUMIRA® (adalimumab) For The Treatment Of Pediatric Patients With Chronic Non-infectious Anterior Uveitis

    AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

  2. Pfizer Announces Positive Top-Line Results From The Comparative REFLECTIONS B7391003 Study For PF-06439535, A Potential Biosimilar To Avastin (bevacizumab)

    Pfizer Inc. recently announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin (bevacizumab), met its primary objective.

  3. Merck Announces U.S. Launch Of RENFLEXIS (infliximab-abda), A Biosimilar Of Remicade, For All Eligible Indications

    Merck, known as MSD outside the United States and Canada, recently announced the U.S. launch of RENFLEXIS (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab). RENFLEXIS was approved by the U.S.

  4. Outsourced Pharma Announces San Diego Conference Session Update

    Outsourced Pharma announces an agenda and panelist update for its Outsourced Pharma San Diego conference to be held in La Jolla on August 22 – 23 2017, at the Hyatt Regency La Jolla. Outsourced Pharma is a conference designed for executives at pharma and biotech sponsor companies who rely on contract development and manufacturing organizations to bring their products to market.

  5. Merck Announces U.S. FDA Grants Tentative Approval For LUSDUNA Nexvue (Insulin Glargine Injection), A Follow-On Biologic Basal Insulin

    Merck, known as MSD outside of the United States and Canada, recently announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device.

  6. Merck And Pfizer Collaborate With Corning To Modernize Pharmaceutical Glass Packaging

    Merck, Pfizer and Corning Incorporated recently announced collaborations that have enabled the modernization of pharmaceutical packaging with the introduction of Corning Valor Glass.

  7. Biosimilars Forum Makes Available Xcenda Study On Budgetary Impact Of Biosimilars Coding

    The Biosimilars Forum published the Xcenda study, "Estimating the Budgetary Impact of Biosimilar Coding Policies Under Medicare Part B," relating to CMS reimbursement of biosimilars

  8. Eylea Will Dominate The Wet Age-Related Macular Degeneration Market Until 2018, When Its Share Will Become Threatened By Emerging Products

    Decision Resources Group finds that over the next ten years, the market for late age-related macular degeneration (AMD) therapies will become fragmented as additional branded vascular endothelial growth factor (VEGF) inhibitors and biosimilar products launch for wet AMD.

  9. PCMA Issues Guiding Principles, Policy Solutions To HHS On Reducing Prescription Drug Costs

    The Pharmaceutical Care Management Association (PCMA) recently submitted a letter to HHS Secretary Tom Price offering policy solutions to reduce prescription drug costs and a list of guiding principles on how the prescription drug marketplace works.

  10. Life Science Connect Announces The Acquisition Of Industry Standard Research

    Today Life Science Connect (LSC), a leading B2B marketing services and engagement company, announced the acquisition of Industry Standard Research (ISR), also known as ISR Reports.