Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson's autoimmune drug ...

By Rishika Sadam HYDERABAD (Reuters) - (This Feb.19 story has been corrected to say that generic drugs overall, not just ...

Number 4: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis ...

In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference ...

BioMarin's gene therapy pipeline has had setbacks, including a three-year delay in US approval of Roctavian and stalled development of PKU gene therapy BMN 307 as the Food and Drug Administration ...

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar ...

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

Understanding biosimilars, biologics, and the challenges surrounding their regulation and pricing in the pharmaceutical ...

The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated ...

Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day ...

Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of ...