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

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
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