India, Oct. 31 -- image credit- shutterstock

The US Food and Drug Administration (FDA) has announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost "generic" alternatives to biologic drugs that treat serious and chronic diseases.

In a newdraft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.

Expensive biologic medications make up only 5% of prescriptions in the US but account for 51% of total dr...