To understand the class of drugs known as biosimilars, it is first necessary to understand the class of drugs described as biologics. Traditionally, biologics were derived through natural ...

J&J seeks preliminary injunction over Samsung's sublicense deal with private label provider J&J says said sublicense deal would hurt its market share Samsung Bioepis launched its biosimilar in U.S ...

It calls the new drug “Merilog,” a biosimilar to the widely-used insulin product Novolog (insulin aspart). A biosimilar is highly similar to that reference with no clinically meaningful ...

Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and Xgeva. Ospomyv provided similar BMD increases as Prolia for women with osteoporosis in a ...

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have ...

The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for treating adults and children with diabetes.

(Reuters) - Johnson & Johnson sued Samsung Bioepis for allegedly breaching a contract agreement over its launch of a biosimilar to Stelara, J&J's blockbuster psoriasis treatment. The lawsuit ...

(Reuters) - Johnson & Johnson (NYSE:JNJ) sued Samsung (KS:005930) Bioepis for allegedly breaching a contract agreement over its launch of a biosimilar to Stelara, J&J's blockbuster psoriasis ...

Merilog is available in a 3 mL prefilled pen and a 10 mL vial, joining two long-acting insulin biosimilars approved by the FDA in 2021. Merilog, a rapid-acting human insulin analog, is the first ...

Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics ...

THURSDAY 20 FEBRUARY, 2025 - INCHEON, SOUTH KOREA – Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt ...