BPCIA Turns 10: Nearly 100 Drugs Become Biologics

Regulatory NewsRegulatory News | 23 March 2020 |  By 

The law that opened up the approval pathway for biosimilars, known as the Biologics Price Competition and Innovation Act (BPCIA), turned 10 years old on Monday and nearly 100 drugs officially became biologics under what’s known as the “deemed to be a license” provision of the BPCIA.

As anticipated, the shift for these nearly 100 products will mean insulin and treatments for respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and others will be marketed under biologics license applications (BLAs) and see biosimilar competition moving forward.

Last September, FDA listed the products making the transition. And earlier this month, FDA finalized guidance on what this transition means for sponsors of these products. FDA previously released final guidance on the BPCIA provision back in December 2018.

“Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications,” FDA’s Center for Drug Evaluation and Research director Janet Woodcock and principal deputy commissioner Amy Abernethy said in a statement.

And while the biosimilar industry once struggled to launch dozens of products, more than 60% of the FDA-approved biosimilars have now launched and really only the biosimilars for Enbrel (etanercept) and Humira (adalimumab) have yet to materialize.


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