FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable

WHY IT MATTERS

Patients with rare diseases who depend on expensive biologic treatments may gain access to more affordable biosimilar options, potentially reducing out-of-pocket costs and improving treatment accessibility.

The FDA announced new steps to make it easier and faster for companies to develop biosimilar medicines. Biosimilars are drugs that work like existing biologic medicines but are made differently and cost less. These changes could help more affordable versions of expensive biologic drugs reach patients sooner.

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.