Biosimilar Development News

  1. FDA Approves Coherus’ CIMERLI™ (Ranibizumab-eqrn) As The First And Only Interchangeable Biosimilar To Lucentis® For All Five Indications, With 12 Months Of Interchangeability Exclusivity 8/2/2022

    Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy and quality.1 CIMERLI™ belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.

  2. Fresenius Kabi’s Biologics License Application For Biosimilar Candidate Tocilizumab Accepted For Review By The FDA 8/1/2022

    Fresenius Kabi, a global healthcare company that specializes in pharmaceuticals, medical technologies and clinical nutrition products for critical and chronic conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s 351(k) Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra*(tocilizumab). 

  3. Applications For Proposed First-Of-A-Kind Multiple Sclerosis Biosimilar Natalizumab Accepted By US FDA And EMA 7/28/2022

    Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

  4. Prestige Biopharma And Intas Pharmaceuticals Announce Partnership To Commercialize Bevacizumab Biosimilar In The US, Europe, Canada, MENA, Brazil, Mexico, South Africa, CIS And The SEA Countries 7/26/2022

    Prestige Biopharma Limited and Intas Pharmaceuticals Limited (hereafter referred to as “Intas”) today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma’s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.

  5. Sandoz Supplemental Biologics License Application Accepted By US FDA For Biosimilar Hyrimoz (adalimumab-adaz) High Concentration Formulation (HCF) 7/21/2022

    Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz).

  6. The Biosimilars Forum Launches Updated Website Content 7/21/2022

    The Biosimilars Forum updated its website to better educate patients and their healthcare team, lawmakers, payors, and the general public about biosimilars. The website makes information about biosimilars, the development process and regulatory pathway more accessible and easier to understand.

  7. Alvotech Initiates A Pharmacokinetic Study For AVT03, A Proposed Biosimilar For Prolia® And Xgeva® 7/20/2022

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®.

  8. Polpharma Biologics Announces EMA Acceptance Of Marketing Authorization Application For Proposed Biosimilar Natalizumab 7/15/2022

    Polpharma Biologics, an international biotech company dedicated to the development of biosimilars, announced today that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri*.

  9. Bio-Rad Extends Range Of Anti-Idiotypic Antibodies For Bioanalysis And Drug Monitoring 7/13/2022

    Bio-Rad Laboratories, Inc, a global leader in life science research and clinical diagnostic products, extends its range of recombinant monoclonal anti-idiotypic antibodies with the introduction of antibodies specific to brentuximab vedotin (Adcetris), secukinumab (Cosentyx), and the secukinumab–interleukin 17A (IL-17A) drug-target complex.

  10. Implications Of Expanded Biosimilar Use In The United States' Dermatology, Gastroenterology, And Rheumatology Markets Highlighted In New Spherix Study 7/11/2022

    Biosimilars are biopharmaceutical products that are nearly identical copies of drugs that have previously been licensed (reference products), with no clinically meaningful efficacy and safety differences from the reference product. These agents tend to be available at a lower cost point than the branded reference biologics, making them attractive alternative treatment options.