The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.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

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 ...

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 ...

The U.S. Food and Drug Administration (FDA) recently announced the establishment of a public docket to obtain information and comments to help FDA assess how best to advance the development of new ...

(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 ...

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 ...

Predictable reimbursement is a primary operational determinant of biosimilar longevity in practices, frequently outweighing ...

Modernizing biomanufacturing methods and reducing regulatory burdens are key landmarks on India’s roadmap for expanding biosimilars development.

In this week’s edition of InnovationRx, we look at cheaper biologic drugs, Novo Nordisk’s $2 billion next-gen obesity drug deal, new ways of fighting cancer, and more.

AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX ® (onabotulinumtoxinA) to achieve ...

The report reviews the challenge of ASP erosion in Medicare Part B and policy solutions that could ensure patients have access to biosimilars.

Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...