Biosimilar Development News

  1. Kymanox Acquires EU Based Anteris Medical And Anteris Helvetia 2/7/2023

    Leveraging the well-respected anteris brand and team, this acquisition extends Kymanox’s capabilities and geographic reach with a strong European presence.

  2. Fresenius Kabi Announces Global License Agreement With Formycon AG To Commercialize Proposed Ustekinumab Biosimilar 2/2/2023

    Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that it has entered into a global license agreement with Formycon AG, to commercialize a proposed Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG.

  3. First Subject Dosed For Phase 1 Clinical Trial Of Henlius’ Daratumumab Biosimilar HLX15 2/1/2023

    Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 clinical trial of the company's independently developed daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection) in China.

  4. AMJEVITA™ (Adalimumab-Atto), First Biosimilar To Humira®, Now Available In The United States 1/31/2023

    Amgen (NASDAQ:AMGN) today announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.

  5. The Biosimilars Forum Calls On Decisionmakers To Deliver On Humira Biosimilars 1/31/2023

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after Amjevita, the first Humira biosimilar, was launched in the United States. Humira, which can cost upward of $84,000 annually, is the world’s best-selling drug and has faced no U.S. competition amidst a 470% price increase since first introduced.

  6. Sandoz Receives Positive CHMP Opinion For Citrate-Free High Concentration Formulation Of Adalimumab Biosimilar 1/30/2023

    Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab).

  7. Brand Institute's President Of Central European Market Analyzes Drug Brand Name Approvals For Biosimilars 1/26/2023
  8. Hk Inno.N Licenses In Mabxience’s Denosumab Biosimilar 1/25/2023

    HK inno.N said it has signed an exclusive license agreement with Spain’s mAbxience to market the latter’s Prolia (ingredient: denosumab) biosimilar, a preventive treatment for osteoporosis and cancer-related skeletal complications, in Korea.

  9. Alvotech And Bioventure Announce Approval Of AVT02 (adalimumab) As Simlandi In Saudi Arabia 1/24/2023

    Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC (“GHH”), the healthcare division of Yas Holding LLC, today announced that the Saudi Food & Drug Authority (“SFDA”) has approved the manufacturing and distribution of AVT02, a biosimilar for Humira® (adalimumab), which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases. The biosimilar will be marketed as Simlandi™ in Saudi Arabia.

  10. Dr. Reddy’s Successfully Completes Full Set Of Clinical Studies Of Its Rituximab Biosimilar For Filing In The U.S., Europe 1/20/2023

    Dr. Reddy’s Laboratories Ltd. hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.