Biosimilar Development News

  1. CVS Health Launches Cordavis 8/23/2023

    CVS Health® (NYSE: CVS) today announced that it has launched Cordavis, a wholly owned subsidiary that will work directly with manufacturers to commercialize and/or co-produce biosimilar products (an FDA approved biologic medication that is highly similar to, and has no clinically meaningful differences from, a biologic medicine already approved by the FDA) for the U.S. pharmaceutical market.

  2. Sandoz Announces Positive Results From Mylight Phase lll Study For Biosimilar Aflibercept 8/15/2023

    Sandoz, a global leader in off-patent medicines, today releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need.

  3. Senderra Specialty Pharmacy Announces That HUMIRA Biosimilar Products Are Now Available To Patients Nationwide 8/11/2023

    Senderra Specialty Pharmacy announced today that patients can access several HUMIRA biosimilar medications through Senderra's pharmaceutical manufacturing partnerships.

  4. Biocon Q1FY24 Revenue At Rs 3,516 Cr, Up 59%; Biosimilars Up 106%; Research Services Up 25% 8/10/2023

    Biocon Ltd, an innovation-led global biopharmaceuticals company, today announced its consolidated financial results for the fiscal first quarter ended June 30, 2023.

  5. National Survey: Biosimilars' Savings Appeal, But Patient Knowledge Lags 8/8/2023

    A national survey from the Biologics Prescribers Collaborative reveals that about half of people who have taken an innovator biologic or follow-on biosimilar report knowing only "a little" about the medications. Cost savings are the factor most likely to motivate patients to switch from an innovator biologic to a biosimilar.

  6. Biosimilars Forum Scientific Publication Identifies Pathway To Streamlined Development For Biosimilars 8/7/2023

    A new peer-reviewed scientific publication from the Biosimilars Forum provides a comprehensive set of recommendations on how biosimilar development should evolve. The recommendations reflect current science and available evidence.

  7. Fresenius Kabi And Formycon Secure U.S. License Date For Proposed Ustekinumab Biosimilar 8/7/2023

    Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars announced today that they have reached a settlement with Johnson & Johnson for the U.S., concerning FYB202, a proposed ustekinumab biosimilar to Stelara.

  8. Boehringer’s Cyltezo Illustrates Intersection Of Price And Regulation In Biosimilar Market, Says GlobalData 8/2/2023

    The loss of exclusivity of AbbVie’s Humira (adalimumab) has become a perfect scenario to test if the Biologics Price Competition and Innovation (BPCI) act in the US can achieve the intention of the law.

  9. Samsung Bioepis & Organon Announce Topline Results From Interchangeability Study Of SB5 Humira Biosimilar 8/1/2023

    Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab).

  10. Prometheus Laboratories Announces Collaboration With Fresenius Kabi On Anser Testing 8/1/2023

    Prometheus Laboratories Inc. ("Prometheus") today announced a collaboration with Fresenius Kabi to support the validation of and access to Anser therapeutic drug monitoring (TDM) services for eligible patients receiving the Fresenius Kabi biosimilar, IDACIO (adalimumab-aacf). Anser testing is utilized by clinicians treating immune-mediated diseases such as Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA) to gain objective information that helps to inform therapeutic decisions.