FDA Draft Guidance on Biosimilar Interchangeability Sets High Standard

The US Food and Drug Administration (FDA) has released some much-anticipated draft guidance on biosimilar interchangeability with its reference product. According to the regulatory agency, biosimilars will need to demonstrate the same clinical results as branded biologics for all approved indications, in order to be considered interchangeable.

This new regulatory framework sets the bar high for makers of biosimilars. In the US, only four biosimilars have been approved to-date, none of which are considered to be interchangeable with their reference product.

Right now, biosimilars need to demonstrate a high degree of similarity to its branded biologic counterpart in order to gain FDA approval. Drugmakers must show that the safety, purity and potency of a biosimilar match that of its reference product.

Unlike generic drugs however, biosimilars are not chemically identical to biologics, which is the reason why prescribers and pharmacists are unable to automatically substitute one for the other. To achieve interchangeable status, drugmakers will have to conduct trials aimed at determining whether switching from a biologic to a biosimilar poses any risk to the patient.

According to the guidance, post-marketing studies for already-approved biologics will not be sufficient to support an application for interchangeability. The FDA will be accepting comments on their draft guidance until March 20, 2017, at which time they will begin to compose their final guidance.

Sandoz’s biosimilar of Amgen’s Neupogen (filgrastim) became the first biosimilar to be approved in the US in 2015. Since then, Sandoz has been granted another biosimilar approval, joining Hospira and Amgen’ approved biosimilars.