It has to be noted that EPO biosimilar comparison studies indicate that the products marketed in Europe vary from those developed and marketed by companies in semi-regulated markets 2,3.

It is well known that the U.S. biosimilar market has developed slower ... The vast majority (36/49) were filed in the European Patent Office (“EPO”). Next, eight were filed in Japan.

Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from ...

At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

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 ...

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference ...

According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1. The FDA has approved two new biosimilars of denosumab for all indications of the ...

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.

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 ...

(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 ...

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 ...