CVS Supports Biogenerics Approval Pathway

By Staff

12/17/2010

US Pharm. 2010;35(12):104.

Testifying before the FDA, a spokesman for CVS Caremark reiterated the company's desire that the agency implement regulations necessary to approve biogeneric drugs under the Affordable Care Act. During a public hearing before the agency in November, Senior Vice President of Specialty Pharmacy Operations Scott Reid addressed the development of an approval pathway for biosimilar and interchangeable biological products.

“Every day CVS Caremark supports patients who depend on specialty and other biotech drugs to provide critical treatment for their serious, chronic conditions, and we have long advocated for the creation of an FDA pathway for approval of biogeneric options,” said Reid. “The availability of biogenerics will not only help health plans, employers, and federal programs manage their drug spend, but, more importantly, it will help make these extremely expensive medicines more affordable for patients.”

During the testimony, Reid said that ensuring that pharmacovigilance programs for biosimilar and interchangeable products are consistent with programs for the innovator products and that additive burdens, which could inhibit patient access, are not imposed on pharmacies managing these programs are key issues. He also urged the FDA to work with the Centers for Medicare and Medicaid Services to establish a regulatory process that not only allows for interchangeability of biologics but also aligns reimbursement incentives for payers, patients, and providers to choose a biogeneric medication.