House Spending Bill Contains a Provision to Treat Chemically Synthesized Polypeptide Products as Biologics

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.
Kelly Davio
December 18, 2019
This week, the House of Representatives approved a $1.4 trillion spending package, and included in the bill is a newly added provision, reported BioWorld, that will allow chemically synthesized polypeptides to be included in the upcoming March 2020 transition of some products to regulation as biologics and biosimilars rather than as drugs and follow-ons.

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

In a statement, the FDA’s deputy commissioner for policy, legislation, and international affairs, Anna Abram, and director of the Center for Drug Evaluation and Research, Janet Woodcock, MD, voiced support for the change.

The previous exclusion of chemically synthesized polypeptides from the regulatory rollover, said Abram and Woodcock, “could hurt potential competition because it means that if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway, but instead would have to submit a new drug application, which could be much more resource-intensive.”

Removing the exclusion, said the regulators, will help patients get access to cheaper drugs sooner—including chemically synthesized insulins—through a more efficient regulatory pathway. They also said that the change will allow for innovation in manufacturing processes, which could have benefits in terms of efficiency.

However, detractors note that the change could have impacts on intellectual property protections for these products, given the fact that biologics are subject to lengthier patent protection than are small-molecule products. Public Citizen, for one, said in a statement that the provision could have the result of “forcing consumers to wait years for affordable medicine.”
 

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