Biosimilar Development News

  1. 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.

  2. 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.

  3. 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).

  4. Drug Inflation Rate Continues Upward Trend At 3.78%: Vizient Pharmacy Market Outlook 1/26/2023

    Vizient, Inc. released its Winter 2023 Pharmacy Market Outlook, forecasting a 3.78% overall drug price inflation rate for the calendar year beginning, July 1, 2023. The rate reflects a moderate rise relative to recent years but also a growing upward trend led by an increase in prices and utilization.

  5. Brand Institute's President Of Central European Market Analyzes Drug Brand Name Approvals For Biosimilars 1/26/2023
  6. 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.

  7. 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.

  8. 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.

  9. Celltrion Healthcare Announces Canadian Approval Of Vegzelma® (bevacizumab For Injection) For The Treatment Of Five Types Of Cancer 1/19/2023
  10. China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar To Actemra (Tocilizumab) 1/16/2023

    Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra® (tocilizumab), in China.