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 ...

Novartis' soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen's blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory ...

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 ...

By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” said Byoungin ...

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 ...

Basel, February 24, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab-ttwe) in the US.From today, the ...

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 ...

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.

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 ...

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 ...

(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 FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. The regulatory ...