President’s Budget Includes Provision to Establish Regulatory Pathway to Approve Generic Biologics

(Washington, DC)-Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement today on the provision in the President’s budget that would create a regulatory pathway to approve generic versions of biologic products. 

PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

“The key to health reform is to improve access to quality care while reducing waste and unnecessary spending. 

“For over a quarter century, generic medicines have increased access and affordability for consumers, employers, labor unions, government agencies, and others.  However, expensive biologics have not faced generic competition, straining payers’ ability to provide affordable drug benefits for these necessary and often life-changing products.

“PCMA strongly supports the provision in the President’s budget that would create a regulatory pathway to approve generic biologics.  This will save billions of dollars for both the public and private sector by introducing competition and will help finance broader health reforms.  It also protects incentives to produce new biologics.”

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