Clinical Studies on Biosimilars

In innovative drug development, three phases, and usually multiple studies per phase, of clinical research are required. In contrast, biosimilar clinical development can be abbreviated because of the breadth of understanding of the reference biologic and if the structural or functional similarity of the biosimilar has been preliminarily demonstrated analytically.  While clinical requirements differ by regulatory agency, in general, two phases of clinical studies are required – a Phase I study to demonstrate similar pharmacokinetics (how a medicine moves through the body) and a Phase II study of pharmacodynamics (effect of the medicine in the body), along with a pivotal study, referred to as Phase III, to demonstrate similar efficacy, safety and immunogenicity to the reference biologic.

  • Extrapolation of Indications in Biosimilars
  • Biosimilars Clinical Trials
  • Toxicological studies
  • Clinical PK/PD studies
  • Targeted cell line development
  • Transgenic animals
  • Case studies, and clinical models
  • Risk management, and quality affairs
  • Clinical trials on major diseases
  • Biosimilars Clinical Studies
  • Aspects of genotoxicity tests

Related Conference of Clinical Studies on Biosimilars

July 03-05, 2017

4th Annual Congress on Drug Discovery & Designing

Bangkok, Thailand
August 10-12, 2017

8th Asian Biologics and Biosimilars Congress

Beijing, China
Sep 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 02-04, 2017

World Congress on Antibiotics: R&D, Market

Atlanta, 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

Clinical Studies on Biosimilars Conference Speakers

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