Nelson Quoted on SCOTUS Ruling Upholding ACA and Biosimilars Regulatory Pathway
Partner Kevin Nelson was quoted on how the U.S. Supreme Court ruling in California v. Texas that rejected a challenge to the constitutionality of the Affordable Care Act (ACA) also saved the approval pathway for biologic products and biosimilars by upholding the Biologics Price Competition and Innovation Act.
Kevin said, “Biosimilar applications and approvals are continuing to increase as companies and FDA are becoming more familiar with the pathway, and it would have been unfortunate had the biosimilar approval process become a collateral casualty of a constitutional challenge.”
He added that with the constitutionality of the ACA being settled for now “Congress should go forward with improving the biosimilar pathway to increase confidence and uptake in biosimilars and to provide incentives for companies in seeking to manufacture lower-cost biosimilar products.”
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