Biogenerics could "save $14B in Rx costs for Medicare Part B," claims report

If the USA's Congress were to create a clear regulatory pathway for follow-on biologics, the Medicare Part B program could save, conservatively, an estimated $14.0 billion on prescription drug costs over the next 10 years, according to an analysis conducted by Engel & Novitt and released by the Pharmaceutical Care Management Association. The PCMA is the national association representing America's pharmacy benefit managers, which lower the cost of prescription drugs for more than 200 million Americans with coverage provided through Fortune 500 company employers, health insurers, labor unions, and Medicare Part D.

FDA lacks regulatory pathway

Life-saving and enhancing biologics can cost tens or even hundreds of thousands of dollars per patient a year so introducing as much competition as possible is vital to making these treatments more accessible to consumers, says the report. Unlike conventional drug products where generic competition is robust, the US Food and Drug Administration lacks a clear regulatory pathway to approve follow-on biologics, or "biogenerics."