The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

One week after releasing its 11-part biosimilar action plan, the US Food and Drug Administration (FDA) announced it will hold a public hearing to gather input on how it can facilitate the development ...

Teva gains exclusive commercialization rights for IV and SC ocrelizumab biosimilar formulations across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey, pending approvals.

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

In the fourth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the Food and Drug Administration’s requirements and standards for approval of biosimilar ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...