Biowaivers & Biosimilars
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2nd International Conference and Exhibition on Biowaivers and Biosimilars, will be organized around the theme "Addressing Novel Strategic Considerations for Biosimilar Market."

2nd International Conference and Exhibition on Biowaivers and Biosimilars, will be organized around the theme "Addressing Novel Strategic Considerations for Biosimilar Market."

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  • 1. Adopting Novel Strategic Considerations for Biosimilar Market OMICS Group Pharmaceutical Conferences
  • 2. The 2nd international conference and Exhibition on Biowaivers & Biosimilars would be held from 23-25 September 2013 at Raleigh, North Carolina, USA.
  • 3. • OMICS Group invites all the participants across the globe to attend the 2nd International Conference and Exhibition on Biowaivers and Biosimilars during September 23-25, 2013 Hilton, Raleigh, North Carolina, USA. • The patent expirations of generics have given a gateway to Biosimilars into the Global Pharmaceutical Economy since last few years. • Though the regulatory prospects upon Follow-on Biologics were not much implemented in past years, the present circumstances of pharmaceutical R&Ds are worried about patent issues with generic drugs and their molecular entities.
  • 4. • The criteria required in filing of biological drugs will be discussed by popular agencies and their representatives in this meeting. • Biosimilars trials and special case reports will be presented to denote the purpose and clinical data requirements for the future growth of Biosimilars and Biowaivers. • Biosimilars-2013 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biowaivers.
  • 5. • Biosimilars or Biologics are biological medical products made or derived from the active drug substance of a living organism by recombination of DNA or Controlled gene expression methods. . • This term is often used to describe the officially approved subsequent versions of innovator biopharmaceutical medicines from different producers following the patent expiry. • Biologics exhibit high molecular complexity and are sensitive to manufacturing process. Since copied biological products perform differently from the originally branded product, they might produce severe health consequences. Countries like USA therefore are accepting only a few subsequent versions of biologics.
  • 6. Biowaivers • Biowaivers are official waive off for a particular drug from the bioequivalence studies. Generic drugs must enter into commercial market only after they attain clean chit in bioequivalence studies. It is more of a regulatory assessment of therapeutic equivalence of a generic drug with that of the original one. • Clinical studies are conducted for the new drug to replace the existing one. Under certain conditions, these studies are waived off and the product is directly adopted. • Standard guidelines have been framed in most of the USA and EU countries as for as the Biowaivers are concerned.
  • 7. Biosimilars-2013 • OMICS Group announces the 2nd International Conference and Exhibition on Biowaivers & Biosimilars under the theme 'Addressing Novel Strategic Considerations for Biosimilar Market' would be held from 23-25 September 2013 at Raleigh, North Carolina, USA at a time when the Clinical trials and issues related to generic drugs are under heated discussion. • The global scientific meet gathers the cream of researchers and professors in the concerned domain. The three-day event kicks off with the opening session and speeches by esteemed members of the keynote forum. The presentations and talks are divided into relevant tracks.
  • 8. Eminent Speakers at the event • Michael Retsky, Harvard School of Public Health, USA • Sinerik Ayrapetyan, International Postgraduate Educational Center, Armenia • Jeff Lyons, Absorption Systems, USA • Ivo Abraham, Center for Health Outcomes & PharmacoEconomic Research, USA • Arturo Solis Herrera, Center for the Study of Human Photosynthesis, Mexico
  • 9. Major Tracks for the discussion • Challenges and Regulatory Approach for Biosimilars • Emerging Biosimilars in Therapeutics • Clinical Studies and Clinicians Prospects for Biosimilars • Globalization of Biosimilars • Biosimilars Innovator Pharmaceutical Products • Analytical Strategies • Bioequivalence Assessment • BCS & IVIVC Based Biowaivers • Plant Produced Biosimilar Products
  • 10. • Biosimilars-2013 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biowaivers. • For more details on Biosimilars-2013 conference, please visit: http://www.omicsgroup.com/conferences/biowaiv ers-biosimilars-2013/
  • 11. For further details contact • Badoni Victor Biosimilars-2013 Organizing Committee Pharmaceutical Conferences 5716 Corsa Ave, Suite110 Westlake, Los Angeles CA-91362-7354, USA Office +1- 650-268-9744 Toll No +1-800-216-6499 (USA & Canada) Email: biosimilars2013@omicsonline.net • Badoni Victor OMICS Group Incorporation +1- 650-268-9744 email us here