Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products Administration (NMPA) for marketing authorization (drug approval number: Sinopharm S20220008). Junmaikang® is used for the treatment of rheumatoid arthritis, ankylosing spondylitis,…
On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. SEMGLEE (insulin glargine-yfgn) injection launched last year in the U.S. as the first-ever interchangeable biosimilar approved…
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a…
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting. SB5 received EU marketing authorization in August 2017. According to the presentation, the…
Earlier this week, the PTAB instituted inter partes review of two patents directed to methods of treating rheumatoid arthritis by subcutaneously administering tocilizumab and devices for subcutaneously administering tocilizumab, respectively. Fresenius filed petitions for inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche,…
On February 18, 2022, in the first and second wave suits filed by AbbVie Inc. et al. (AbbVie) against Alvotech hf. (Alvotech) regarding an adalimumab biosimilar, AbbVie filed a motion to strike Alvotech’s Final Invalidity and Unenforceability Contentions and a memorandum in support thereof. AbbVie moved the Court to strike…
Earlier this month, Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer and metastatic gastric cancer. ONTRUZANT is Samsung Bioepis’ fifth biosimilar approved for the use in Canada…
On February 4, 2022, Nova Scotia announced that as part of the Nova Scotia biosimilar initiative, Nova Scotians enrolled in Pharmacare programs will have 12 months (until February 3, 2023) to work with their healthcare providers to switch from originator biologics to the biosimilar version of their drug. Where patients…
On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane, and Xbrane will be responsible…
On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). According to the Senate…