Biosimilar Development News

  1. PCMA: Greater Competition On Insulin Products Key To Reducing Prices
    4/10/2019

    The Pharmaceutical Care Management Association (PCMA) applauds the Energy and Commerce Subcommittee on Oversight and Investigations for holding today's hearing on the important issue of rising insulin prices.

  2. Alvotech And Fuji Pharma Announce Agreement
    4/9/2019

    Alvotech and Fuji pharma have entered into a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar (Stelara) in Japan. 

  3. Generium Launches First Biosimilar Of Eculizumab; Becomes Fifth Marketed Product Using Selexis SUREtechnology Platform
    4/9/2019

    Selexis SA and Generium JSC recently announced that a fifth Selexis SUREtechnology Platform-generated biological product has been approved for marketing.

  4. AAM Statement On House Energy & Commerce Passage Of The CREATES Act
    4/4/2019

    The Association for Accessible Medicines welcomes recently’s unanimous 51-0 passage of the CREATES Act by the House Energy and Commerce Committee.

  5. Fresenius Kabi Receives European Commission Approval For Adalimumab Biosimilar IDACIO
    4/3/2019

    Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announced recently that the European Commission (EC) granted marketing authorization for IDACIO, an adalimumab biosimilar, for all indications of the reference medicine.

  6. Sandoz Resubmits Biosimilar Pegfilgrastim Application To US FDA
    4/3/2019

    Sandoz, a Novartis division and a global leader in biosimilars, today announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.

  7. Statement From FDA Commissioner Scott Gottlieb, M.D., On The Agency's Continued Efforts To Bring Competition To The Insulin Market To Lower Prices And Expand Access
    4/2/2019

    Access to affordable insulin can be a matter of life and death for Americans with diabetes. Insulin is a critical hormone that regulates sugar metabolism.

  8. American College Of Rheumatology Targets Step Therapy And Drug Pricing In New Position Statements
    4/1/2019

    The American College of Rheumatology (ACR) has released new drug pricing and step therapy position statements that they hope legislators will consider as they continue to explore policy and regulatory options to make drugs more affordable and accessible.

  9. Data Published In The Lancet Shows That CT-P13 Is Non-Inferior To Reference Infliximab In Inflammatory Bowel Disease
    3/28/2019

    Celltrion Healthcare announced recently that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study.

  10. Interferon Alpha-2a Biosimilar Market Segmentation And Analysis By Recent Trends 2019-2026: Roche, Biosidus, Zydus Cadila
    3/28/2019

    A closer look at the aspects including but not limited to Interferon Alpha-2a Biosimilar market segmentation by the end-user, end-use, geography, type, and application forms an integral part of the research report.