FDA releases draft guidance on container closure and device components for biosimilar combination products

The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products.

The guidance focuses on components such as prefilled syringes and autoinjector pens, outlining the information sponsors should provide to demonstrate safety and efficacy.

By clarifying expectations, the FDA hopes to streamline the regulatory review process for these products, potentially facilitating market entry for biosimilar therapies.