Biosimilars the generic version of biological is the new buzz word in pharmaceutical    industry. Biosimilars are highly similar to licensed reference product not withstanding minor    differences in clinically inactive components; also there are no clinically meaningful differences between the biological and the reference product in terms of safety, purity, and potency. This track includes: Licensing of Biosimilars, Biomarkers regulation, Patent issues, BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Bio waiver approval for Biosimilars and other aspects of Biosimilar approvals.

Therapies based on biologic products have been a disruptive innovation in the pharmaceutical industry due to their success in targeting previously unmet medical needs. Sales of biologics reached 142 billion USD in 2011, equivalent to 19% of the global biopharmaceutical market in terms of revenue  with more than a third of this value (37.6%) captured by the top ten selling biologic products. The size of the market and its evolution from 2004 to 2011 is shown in  highlighting the top ten selling brands: Humira, Enbrel, Remicade, Rituxan, Avastin, Lantus, Herceptin, NovoLog, Neulasta and Lucentis.

Biosimilars  antibodies are “generic” versions of “innovator” (or “originator”) antibodies with the same amino acid sequence, but produced from different clones and manufacturing processes . As a consequence, Biosimilars mAbs may include possible differences in glycosylation and other micro variations such as charge variants that may affect quality, safety and potency. Biosimilars  are known as follow-on biologics in the US but this term is misleading because it could also refer to second and third generation antibodies (that will be defined and illustrated below) and should be avoided. In contrast to the low-cost generic versions of small molecules that are off patent, it is currently not possible to produce exact copies of large proteins and glycoproteins, such as antibodies, owing to their structural complexity, and so the term bio generic should also be avoided.

  • Challenges and regulatory approach for biosimilars
  • Clinical studies and clinicians prospects for biosimilars
  • Biosimilars innovator pharmaceutical products
  • Measurable parameters for customized therapies
  • Future of next generation biosimilars
  • Biosimilar medicines

Related Conference of Biosimilars

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
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

Biosimilars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in