The Top 5 Biosimilar Articles for the Week of August 29

Here are the top 5 biosimilar articles for the week of August 29, 2022.

Hi, I’m Skylar Jeremias 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 August 29, 2022.

Number 5: The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.

Number 4: Hadlima, 1 of 7 FDA-approved biosimilars referencing Humira (adalimumab), now will be offered in a high-concentration, citrate-free (100 mg/mL) version, as the FDA had granted the new formulation regulatory approval.

Number 3: Researchers found that an infliximab biosimilar was as safe and effective as the reference product (Remicade) in pediatric patients with inflammatory bowel disease. However, more studies on adalimumab biosimilars in pediatric patients are needed.

Number 2: Novartis announced that it plans to spin off Sandoz, its generics and biosimilars division, into a new publicly traded, standalone company.

Number 1: Amgen announced that its phase 3 study involving ABP 959, a biosimilar candidate to eculizumab (Soliris), had met its primary endpoints in the DAHLIA study. The biosimilar is being developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other indications.

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