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 updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...

Sandoz is opening a new biosimilar development centre in Ljubljana, Slovenia, to strengthen and expand its in ‑ house ...

The US Food and Drug Administration (FDA) on Friday finalized additional questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act (BPCIA) and made ...

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 ...

Alvotech acquires Xbrane's R&D operations and biosimilar candidate XB003 for ~$27M, expanding into Sweden's life sciences sector. Xbrane retains key preclinical assets, strengthens finances, and ...

Pfizer on Tuesday told Focus that it’s halting the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in ...

(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 ...

--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 ...