Regulatory Focus™ > News Articles > 2019 > 12 > FDA Supports Budget Bill’s Changes to Chemically Synthesized Polypeptides

FDA Supports Budget Bill’s Changes to Chemically Synthesized Polypeptides

Posted 18 December 2019 | By Zachary Brennan 

FDA Supports Budget Bill’s Changes to Chemically Synthesized Polypeptides

A seemingly tiny change buried in the soon-to-be passed government spending bill seemed like a win for the biopharma industry, but the US Food and Drug Administration (FDA) said in a statement late Tuesday that the change would actually increase competition.

The change means that chemically synthesized polypeptides, which had been excluded from the new drug application (NDA) to biologic license application (BLA) switch that’s occurring in March 2020, will now be included and considered as biologics moving forward, so follow-on products will not have to submit a more “resource-intensive” NDA to compete, FDA said.

“Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured,” FDA said. “In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.”

The agency further explained that if such an exclusion was not enacted, chemically synthesized polypeptides would not be able to come to market through the generic drug pathway because the originator product will be classified as a biologic.

But nonprofit Public Citizen maintained that the provision (Subtitle F, Section 605 of the spending bill) will give these products longer market exclusivity (biologics get 12 years exclusivity, whereas small molecule drugs get five years), which inevitably means people will have to wait longer for affordable chemically synthesized polypeptide competitors.

FDA Statement


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