Biosimilar Development News

  1. Sandoz Resubmits Biosimilar Pegfilgrastim Application To US FDA

    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.

  2. 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

    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.

  3. American College Of Rheumatology Targets Step Therapy And Drug Pricing In New Position Statements

    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.

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

    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.

  5. Lupin And YL Biologics Receives PMDA Approval For Etanercept Biosimilar In Japan

    Pharma major Lupin Limited (Lupin) announced that YL Biologics Limited (YLB), a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo Inc. in Japan, and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry Co. Ltd) have received an approval to manufacture and sell their biosimilar Etanercept in Japan. The approval to treat moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis was received today.

  6. Obtainment Of Manufacturing And Sales Approval For Etanercept Biosimilar, Anti-Rheumatoid Arthritis Agent

    YL Biologics Ltd. (Head office: Chuo-ku, Tokyo, President and Representative Director: Toshihiko Hibino), Yoshindo Inc. (Head Office: Toyama City, Toyama, President and Representative Director: Hiroki Kitamura) and Teijin Ltd. (Head office: Kita-ku, Osaka, President and CEO: Jun Suzuki) have announced that on March 26, 2019, YL Biologics obtained manufacturing and sales approval for Etanercept biosimilar, an agent for anti-rheumatoid arthritis and polyarticular course juvenile idiopathic arthritis (Development code: YLB113) which YL Biologics has developed globally.

  7. Biosimilars Market To Reach USD 44.56 Billion By Year 2026 | Reports And Data

    According to the current analysis of Reports and Data, the global Biosimilars market was valued at USD 5.10 Billion in 2018 and is expected to reach USD 44.56 Billion by year 2026, at a CAGR of 30.8%. Biosimilar are alternatives to existing patented, and approved biologics and possess similar medicinal properties as compared to the original biologics.

  8. FDA Accepts The Citizen Petition By Prof. Niazi, To Withdraw The Naming Guidance For Biosimilars

    Fast responding to Scott Gottlieb, FDA Commissioner's statement on 7th March that the naming guide that requires a four letter suffix attached to the nonproprietary name of biological drugs will now only apply to biosimilars, Prof. Niazi, filed a citizen petition demanding the FDA to withdraw the guidance to prevent vested interests from misguiding prescribers and patients that biosimilars have different safety and efficacy. The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.

  9. Significant Healthcare Savings Possible If U.S. Cultivates A Robust Biosimilars Market

    The Biosimilars Forum and Medicines for Europe released a joint report recently exploring how European countries have successfully instituted and sustained a multi-source, competitive biosimilars market over the last decade.

  10. Coherus BioSciences Receives Transitional Pass-Through Status From CMS

    Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced that the Centers for Medicare and Medicaid Services (CMS) approved UDENYCA™ (pegfilgrastim-cbqv) biosimilar for transitional pass-through payment status in the hospital outpatient setting. Effective April 1, 2019, UDENYCA™ is granted 36 months of transitional pass-through status.