Companies Discuss Biosimilars, Suggest Reforms at FDA Public Meeting

Regulatory NewsRegulatory News | 04 September 2018 |  By 

Advocates for biosimilars and their reference products came together Tuesday at the US Food and Drug Administration (FDA) to discuss various ways to better facilitate competition in the biologics marketplace.

Many of the speakers discussed ways in which the Purple Book should be reformed, particularly with new additions to make it a more useful resource, while others pushed for ways to increase biosimilar uptake and transparency.

Kicking off the meeting, Andrew Greenspan, VP of medical affairs at Janssen Biotech, took the reference products’ side, calling for FDA to require biosimilar to biosimilar switching studies, though he was later questioned on the need for such studies and asked to discuss how such switching would be different from switching between different products in the same class. Greenspan further called for FDA to require post-marketing studies to better track biosimilars once they are on the market.

Nathan Doty of AbbVie similarly took the side of reference products, claiming there is no clinical data to justify switching between interchangeable biosimilars of the same reference product, and that the Purple Book should make such a declaration.

On the other side of the debate, Juliana Reed, president of the Biosimilars Forum, called on FDA to make the Purple Book more useful by providing the date of exclusivity expiration for reference products and how long it took for biosimilars to be approved and to let developers know which center – CBER or CDER – regulates which products.

Mariana Socal of Johns Hopkins also called for new additions to the Purple Book, including unexpired exclusivity periods, saying, “FDA should make a determination on first licensure dates on all FDA-licensed biologics.”

Reed, meanwhile, touched on a rumor that the suffixes attached at the end of biosimilars' names will not be added retroactively to all biologics, as had initially been decided. The Biosimilars Forum is now calling for suffixes to be added to all reference products to avoid negative perceptions of biosimilars.

Richard Markus of Amgen also noted the cost of procuring reference product is less than 5% of process development and manufacturing costs, and decreasing the number of reference product lots tested may lead to uncertainty. Though Markus did say that use of a non-US-licensed comparator may be appropriate in some cases.

And on the topic of interchangeable biosimilars, Markus noted that only about 10% of biologics reported to lose exclusivity through 2023 are dispensed via the pharmacy. He also explained some circumstances where an expedited review might be warranted.

Meni Melek of Novartis called for FDA to prioritize staffing to better meet user fee-related goals.

Lisa Skeens at Pfizer also called to optimize biosimilar development, combatting misinformation (as the company did with its latest citizen petition) and expediting access to biosimilars. She also called for the dismissal of contracts that require patients to fail first on reference products.

FDA Commissioner Scott Gottlieb also spoke, noting the important role FDA plays in ensuring access to affordable medicines. “The high costs of biologics are likely familiar to you,” he told participants, noting that it will take more work to ensure a vibrant biosimilar marketplace.

“I’m not satisfied with the current state of the market,” Gottlieb added.


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