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 ...

PE: How are global regulatory agencies adjusting their policies for biosimilars? Woollett: The clear leaders in the space of biosimilar development have been the European agency, the UK, and US FDA.

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 ...

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 ...

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

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 ...

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The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.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

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 ...

--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/ - ...