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

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

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative ...

HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. This presents a golden opportunity for Contract Manufacturing ...

Enzeevum, a biosimilar to Eylea, is approved in Canada for multiple retinal conditions, expanding treatment options for ophthalmologists. Biosimilars may offer cost-effective alternatives, potentially ...

The Food and Drug Administration announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. Despite the decline in overall ...

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 ...

WASHINGTON (Reuters) -The U.S. Food and Drug Administration on Wednesday said it is aiming to reduce the number of human clinical studies required for approval of certain biosimilar drugs and cut ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...

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 ...