Biosimilars offer substantial promise for a new era of accessibility and affordability for patients and the broader health care industry, but better understanding of these products from payers and ...

A Q&A with Sophia Humphreys, PharmD, MHA, BCBBS; Robert Gluckman, MD, MACP; and Elie M. Bahou, PharmD, MBA. Bahou detailed that his approach to integrating biosimilars into his organization revolves ...

Organon & Co. (NYSE:OGN), a global healthcare company spun off from Merck (NSE:PROR) in 2021, has established itself as a leader in women's health while expanding its presence in biosimilars and ...

The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the ...

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 ...

It’s been two years since the Inflation Reduction Act (IRA) was passed, and, while the law's Medicare-negotiated price cuts haven’t yet gone into effect, a change surrounding biosimilar reimbursement ...

A biosimilar drug manufacturer is concentrating on process optimization to increase uptake of its products in lower-income countries. According to Jeffrey Hausfeld, MD, chairman of the board of ...

No biosimilar producers have made use of an accelerated US approval pathway introduced in 2010, and now the first case has found against a biosimilar for Enbrel. George Yu and Jason Harp explain where ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

Biosimilars are near-identical versions of biologic cancer drugs, available at lower costs. Germany saves hundreds of millions annually from just one biosimilar drug. Patient mistrust and policy ...

Biosimilars offer increased patient choice and potential cost-savings, compared with originator biologics. We studied 3 years of prescribed biologics among US physician practices to determine the ...