The FDA's take on Biosimilars

By Dr Nicola Davies

As many first-generation biologics reach the end of their patent life, biosimilars have the potential to bring about much-needed cost savings for the US healthcare system by increasing competition and driving down prices.1,2 However, writes Dr Nicola Davies in her regular exclusive FDA Blog for The Pharma Letter, biosimilar developers must overcome the US Food and Drug Administration’s regulatory requirements to gain access to the world’s largest pharmaceutical market.3

Under the former President Barak Obama, the current regulatory pathway started when the Biologics Price Competition and Innovation Act (BPCI Act) was first legislated in March 2010.4 The BPCI Act, enacted under the Affordable Care Act, enabled applicants to obtain expedited approval for biologic products shown to be highly similar to an FDA-approved reference product.