Litigation Restricts Cash-Poor on U.S. Biosimilar Path

By Asthika Goonewardene, Pharmaceuticals Equity Research Analyst, Bloomberg Industries

The cost of allegations that process patents may have been infringed under a biosimilar application may deter small generic developers from pursuing approval through the 351(k) pathway, which was specifically set up for copies of cheaper biologic drugs.

The FDA created an abbreviated pathway for generic companies to demonstrate that a proposed biological product is biosimilar to an FDA-approved biological product or “reference product” under section 351(k) of the Public Health Service Act (PHS Act).

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