Biosimilars & Generics

In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.

Instead of requiring a three-way pharmacokinetic bridging study that compares the US reference product, foreign reference product and proposed biosimilar, a sponsor should justify the relevance of clinical data comparing a proposed biosimilar to a foreign product.

During a candid and revealing discussion, lobbying experts shared strategies for getting the generics and biosimilars industry’s message heard by lawmakers.

As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’

Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.

Ascent had hoped to join a growing list of US mirabegron competitors, but a Delaware court found its ANDA would infringe valid Astellas patents covering the sustained-release formulation.

As the US Supreme Court prepares to review litigation on generics with carved-out indications, or skinny-labels, Hikma once again won the the US solicitor general's support.

The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.