Legal Issues and BPCI Act

The legal issues pertaining to the the follow-on-biologics and biosimilars are one of the most aspects that requires an open discussion. Before the actual advent of biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law.

By 2002, the FDA had approved 36 new biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

  • Implimentation of the BPCI Act
  • Patent protection and infringement issues
  • Patent negotiation and litigation phase
  • Market exclusivities

Related Conference of Legal Issues and BPCI Act

October 19-20, 2017

9th Annual Congress on Drug Design & Drug Formulation

Seoul, South Korea
October 19-20, 2017

4th International Conference and Exhibition on Pain Medicine

(10 Plenary Forums - 1 Event)
San Francisco, California, USA
October 30-November 01, 2017
A B2B Networking & Global Knowledge Exchange Forum

Annual Congress on Emerging Orphan Drugs and  Rare Diseases

San Antonio, Texas, USA
April 20-21, 2018

4th International Conference on Antibiotics: R&D, B2B

Las Vegas, Nevada, USA
April 26-27, 2018

11th European Biosimilars Congress

Rome, Italy
May 07-09, 2018

15th Annual European Pharma Congress

Frankfurt, Germany
June 18-19, 2018

9th Global Experts Meeting on Neuropharmacology

Paris, France
June 20-22, 2018

7th World Congress on Mass Spectrometry

Rome, Italy
July 09-10, 2018

12th Global
Pharmacovigilance & Clinical Trials Summit

Sydney, Australia
July 16-18, 2018

5th World Congress on Green Chemistry and Green Engineering

Melbourne, Australia
July 16-18, 2018

15th Asia-Pacific Pharma Congress

Melbourne, Australia
Jul 30-Aug 01, 2018

10th World Congress on Pharmacology

Barcelona, Spain
September 13-14, 2018

8th World Congress on Chromatography

Prague, Czech Republic
September 24-26, 2018

7th International Conference on Clinical Trials

Chicago, USA
(10 Plenary Forums - 1 Event)
October 22-23, 2018

18th Annual Pharma Middle East Congress

Abu Dhabi, UAE
November 05-06, 2018

18th Annual Pharmaceutical Chemical Analysis Congress

Madrid, Spain

Legal Issues and BPCI Act Conference Speakers

Recommended Sessions

Related Journals

Are you interested in