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 ...

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

This article was published in Scientific American’s former blog network and reflects the views of the author, not necessarily those of Scientific American Even if you have never heard of biosimilar ...

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available ...

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s agenda since he took office in January. He has taken a number of steps, including striking deals with ...

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 ...

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions ...

The FDA recently designated Yuflyma as "interchangeable" with the popular biologic Humira for the treatment of Crohn's disease and ulcerative colitis, two types of inflammatory bowel disease (IBD), ...

Biocon recently unveiled three new biosimilar oncology assets to its R&D pipeline —trastuzumab/hyaluronidase (Herceptin ...

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 ...

Samsung Bioepis released its Q1 2026 Biosimilar Market Report, which provides an overview of the market status of all ...

Ondibta is approved for the treatment of diabetes mellitus in adults, adolescents and in children aged two years old and ...