Biosimilars- Hatch-Waxman Act & BPCI Act

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. The act provides some protection for drug innovators while facilitating and providing incentives for companies to file ANDAs.

Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. FDA requires licensed biosimilar and interchangeable biological products to meet the Agency’s rigorous standards of safety and efficacy.  That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. This track includes:

Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. FDA requires licensed biosimilar and interchangeable biological products to meet the Agency’s rigorous standards of safety and efficacy.  That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.

  • Regulatory prospects of BRIC countries
  • Critical regulatory issues
  • Recent Patent disputes and litigations
  • Criteria for Patentability and Patent Claims
  • Licensing of biosimilars
  • BLA filing for biosimilars
  • Biosimilars pricing regulation

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