The FDA approved Nufymco as an interchangeable biosimilar to Lucentis, making it the second approved ranibizumab biosimilar ...

Alvotech, a biotech firm focused on biosimilar medicine development, announced the acquisition of Xbrane Biopharma’s R&D operations and a biosimilar candidate named XB003, aimed at extending its ...

The biosimilar market is set for growth as patents on major biologics expire, creating opportunities for affordable alternatives. Key areas in biosimilar development include regulatory pathways, EU/US ...

In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development ...

This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...

--Analysis of Pivotal Trial Results of Insulin Glargine Nearly Completed, BLA Filing Timeline Slightly Delayed, But Potential Launch Timing Remains in Range-- TREVOSE, Pa., Jan. 4, 2023 /PRNewswire/ - ...

In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that the U.S. should throw in the towel on copycat versions of the nation’s highest priced ...