CVS Caremark supports FDA pathway for approval of biogeneric options

Nov 3 2010

CVS Caremark reiterated the company's support that the U.S. Food and Drug Administration (FDA) implement regulations necessary to approve biogeneric drugs under the Affordable Care Act. The company's Senior Vice President of Specialty Pharmacy Operations, Scott Reid, testified before the FDA today during a public hearing to address the development of an approval pathway for biosimilar and interchangeable biological products held at the agency's headquarters in Silver Spring, Maryland.

"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."

Reid's comments to the agency also touched on ensuring that pharmacovigilance programs for biosimilar and interchangeable products are consistent with programs for the innovator products and that additive burdens, that could inhibit patient access, are not imposed on pharmacies at the front lines of managing these programs.  He also urged the FDA to work with the Centers of 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.

SOURCE CVS Caremark