What are biosimilars?

Biosimilars are biological products that are highly similar to an existing biologic therapeutic that is already approved. Biosimilars can be approved through an abbreviated regulatory pathway and have the potential to provide more cost-effective treatment choices for patients. These benefits hold great promise to help increase the availability of quality biologic medicines for conditions ranging from diabetes to cancer.

How can USP help?

USP encourages innovation in the field of biopharmaceuticals with guidance and standards for emerging technologies and processes while maintaining the highest standards of quality and safety. To help expand the supply of biosimilars, USP provides materials and quality standards that manufacturers can use to develop, validate and monitor analytical methods used to test biological treatment quality from raw materials through production and release. USP’s current work on biosimilars focuses on standards and tools that may apply to groups of related products, such as monoclonal antibodies rather than a specific product.

What’s the goal?

Ultimately, USP is working towards establishing and maintaining standards for biologics, including biosimilars, that safeguard their quality, safety, and effectiveness, to the benefit of both patients and healthcare systems.