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

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

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 ...

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 ...

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 ...

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

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 ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

This official FDA action marks the culmination of a fifteen-year scientific and regulatory effort led by Professor Niazi, who has consistently argued that CES add no meaningful value to biosimilar ...

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), ...