Expert: Biosimilar Legislation Making Moves in the Right Direction

Biosimilar therapies might be here to stay, but the regulatory landscape around these products is still evolving, said Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora. “There are several legislative efforts currently in motion to address several perceived impediments to the biosimilar approvals and launches that we see today.”

Numerous bills have been introduced since Congress passed the Biologics Price Competition Innovation Act of 2009, legislation that created “an abbreviated approval pathway to help provide patients with greater access to safe and effective biological products.”1 Farmer pointed to a recent bill introduced to Congress aimed at preventing product hopping, a practice where innovator product companies seek to extend exclusivity by switching patients to new or slightly changed versions of a reference product. “As we know, tactics like this can stall the ability to introduce new biosimilars to the market, as well as possibly hinders approved biosimilars from having full access to all of the originator product indications, which forces [these biosimilars] to have a skinny label approval,” Farmer said.

Skinny labels, she added, have demonstrated some benefits in the space due to their ability to avoid originator patent walls; however, these labels may also potentially hinder biosimilar adoption due to providers’ reluctance to prescribe a therapy that is not FDA approved for all indications.

“The good news is, although we are still making strides from a legislative standpoint, I believe that those strides are moving in the right direction,” Farmer said. “I am very hopeful and optimistic that we can expect to see even more legislative support of the biosimilar industry as it continues to grow in the coming years.”

Farmer sat down with Drug Topics at AXS24, the Asembia Specialty Pharmacy Summit, held April 28 to May 2 in Las Vegas, Nevada. Click here for more of our coverage from AXS24.

Reference

1. Biological product innovation and competition. FDA. Reviewed April 10, 2024. Accessed May 1, 2024. https://www.fda.gov/drugs/biosimilars/biological-product-innovation-and-competition