Reach Us +1-217-403-9671
PEG-Modified Biosimilars: Potential Role In The Emerging Global Biosimilar Market | 8172
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

PEG-Modified biosimilars: Potential role in the emerging global biosimilar market

International Conference and Exhibition on Biowaivers & Biosimilars

Pascal Bailon

ScientificTracks Abstracts: J Bioequiv Availab

DOI: 10.4172/0975-0851.S1.002

The newly amended Public Health Service (PHS) Act clears the way for an abbreviated licensure pathway to ?Biosimilars? or to ?Interchangeable? with an FDA approved biological product. Now it is only a matter of time biosimilars hit the US, Japan and other world markets, if it isn?t already. EU has several Biosimilars presently in the market. However, Biosimilars suffer the same clinical shortcomings as that of the original ?innovator? molecules, such as short circulating half-life, immunogenicity and proteolytic degradation, among others.This is especially true for cytokines, hormones, growth factors and antibody fragments. These shortcomings could be circumvented by the application of the well-established and proven PEGylation technology to biosimilars. In this presentation, the rationale, and clinical development strategies including reasonable timelines are presented. In order to be attractive to the medical community and to be competitive in the market place, PEG-biosimilars must be safe, more potent, longer-acting and cost-effective compared to their corresponding innovator biomolecules.
Pascal Bailon is a retired Research Director from Hoffmann-La Roche, Inc., Nutley, NJ. He is the inventor and patent holder of the APIs of Pegasys? for the treatment of hepatitis C, Mircera?, for the treatment of renal anemia and the first ever Receptor-Affinity Chromatography for the purification of fully refolded and monomeric rIL-2 from inclusion bodies. He had published in prestigious journals, like Nature, Biotechnology, PNAS and Blood, among others. He had edited the book on Affinity Chromatography Methods and Protocols. He is the recipient of numerous awards for his scientific contributions.