FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs.

The agency published a draft guidance for industry Wednesday that would potentially make it faster and loss costly for companies to develop biologics and bring them to market, leading to increased competition and lower drug costs for patients.

The agency proposed that human studies might not always be necessary to prove that the product is similar enough to an existing FDA-approved biologic.

Instead, the guidance allows developers to rely on analytical testing to demonstrate product differences.

“We don't have these additional requirements for generics. Moving forward, we're not going to have them for b