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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

A meaningful US access gap persists for off-patent biologics lacking viable biosimilar programs, especially mid-tier products ...

Manufacturers of generic and biosimilar medicines should rethink their real world launch, lifecycle and litigation strategies ...

While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant ...

The Biosimilars Market is set to witness a CAGR of 15% in the next 5 years. Impending patent expiry of blockbuster biologics, ...

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 ...

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. Samsung Bioepis announced a licensing, ...

Panelists discuss how biosimilar manufacturers can increase uptake by ensuring positive financial outcomes for all stakeholders, maintaining strong patient assistance programs, and working closely ...

Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars are gradually making inroads in the outpatient drug ...

Within ten years, a patient may find that even a decades-old biologic treatment option they need has no other lower-cost alternative — and the one that’s available is prohibitively expensive and not ...

Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for these ...

"Depending on what prices CMS sets," writes health expert Sally Pipes, "it may be impossible for biosimilar manufacturers to sell at a price low enough for patients." Officials at the Centers for ...