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:

  • 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

Related Conference of Biosimilars- Hatch-Waxman Act & BPCI Act

August 10-12, 2017

8th Asian Biologics and Biosimilars Congress

Beijing, China
September 20-21, 2017

10th Pharmacovigilance Congress

Charlotte, North Carolina, USA
September 25-26, 2017(10 Plenary Forums- 1 Event)

7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Chicago, Illinois, USA
September 25-26, 2017
(10 Plenary Forums - 1Event)

6th International Conference and Exhibition on GMP, GCP & Quality Control

Chicago, Illinois, USA
October 16-18, 2017

12th World Pharma Congress

Budapest, Hungary
October 16-18, 2017

11th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
Baltimore, Maryland, USA
October 16-17, 2017

10th International Conference and Exhibition on Biologics and Biosimilars

San Francisco, California, USA
November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria

Biosimilars- Hatch-Waxman Act & BPCI Act Conference Speakers

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