Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an ...

As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...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

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

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 ...

Alvotech has five approved drugs, including biosimilars of AbbVie's Humira, Johnson & Johnson's Stelara/Simponi, and Eylea. See why ALVO stock is a Strong Buy.

Biosimilars are driving down drug costs, expanding access to critical treatments, and creating space for future innovation. In this episode, Linda Choi MacDonald, EVP and Global Head of Commercial at ...

Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...

The release of a recent EMA reflection paper, aligning with FDA and WHO positions, has resulted in a renewed focus on the central role of pharmacokinetic (PK) data, the primary status of analytical ...

Owen Hosseinzadeh, Maarika Kimbrell, Christina Macdougall, Ph.d. FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: ...