An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

(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 ...

Dublin, Dec. 23, 2025 (GLOBE NEWSWIRE) -- The "Biosimilars Training Course (Mar 16th - Mar 17th, 2026)" training has been added to ResearchAndMarkets.com's offering. In today's pharmaceutical ...

(RTTNews) - Alvotech (ALVO) announced on Thursday that it has acquired Xbrane Biopharma AB's R&D operations and biosimilar candidate XB003, further enhancing its position in the biosimilars ...

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 ...

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative ...

Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks ...

The global biosimilar monoclonal antibody market revenue was around US$ 10.6 billion in 2023 and is estimated to reach US$ 64.7 billion by 2032, growing at a compound annual growth rate (CAGR) of 22.2 ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...