An appeals court has upheld a District Court’s denial of a preliminary injunction for Amgen’s (AMGN) Eylea biosimilar, which UBS analyst Trung ...

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 ...

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 ...

Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab biosimilars referencing Prolia and XGEVA. mAbxience ...

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 ...

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 ...

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 ...

The UK health service has well over a decade’s experience of dealing with biosimilars, but the NHS acknowledges that it has yet to make the most of these drugs. That was certainly one of the ...

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 ...

(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 ...

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.