The Top 5 Biosimilar Articles for the Week of December 19


Here are the top 5 biosimilar articles for the week of December 19, 2022.

Hi, I’m Hayden Klein for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of December 19, 2022.

Number 5: The FDA has accepted Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.

Number 4: A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.

Number 3: Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

Number 2: Johnson & Johnson’s Janssen unit filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

Number 1: Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

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