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AdoptingAdopting NovelNovel StrategicStrategic ConsiderationsConsiderations forfor BiosimilarBiosimilar MarketMarket
AdoptingAdopting NovelNovel StrategicStrategic ConsiderationsConsiderations forfor BiosimilarBiosimilar MarketMarket
AdoptingAdopting NovelNovel StrategicStrategic ConsiderationsConsiderations forfor BiosimilarBiosimilar MarketMarket
AdoptingAdopting NovelNovel StrategicStrategic ConsiderationsConsiderations forfor BiosimilarBiosimilar MarketMarket
AdoptingAdopting NovelNovel StrategicStrategic
ConsiderationsConsiderations forfor BiosimilarBiosimilar
MarketMarket
OMICS Group Pharmaceutical
Conferences
ConsiderationsConsiderations forfor BiosimilarBiosimilar MarketMarket OMICS Group Pharmaceutical Conferences
SeptemberSeptember 20132013 atat Raleigh,Raleigh, NorthNorth Carolina,Carolina, USAUSA TheThe 2nd2nd
SeptemberSeptember 20132013 atat Raleigh,Raleigh, NorthNorth Carolina,Carolina, USAUSA TheThe 2nd2nd
SeptemberSeptember 20132013 atat Raleigh,Raleigh, NorthNorth Carolina,Carolina, USAUSA
SeptemberSeptember 20132013 atat Raleigh,Raleigh, NorthNorth Carolina,Carolina, USAUSA
atat Raleigh,Raleigh, NorthNorth Carolina,Carolina, USAUSA TheThe 2nd2nd internationalinternational

TheThe 2nd2nd internationalinternational conferenceconference andand ExhibitionExhibition onon BiowaiversBiowaivers && BiosimilarsBiosimilars wouldwould bebe heldheld fromfrom 2323--2525

onon BiowaiversBiowaivers && BiosimilarsBiosimilars wouldwould bebe heldheld fromfrom 2323--2525
• OMICS Group invites all the participants across the globe to attend the 2 nd
• OMICS Group invites all the participants across the globe to attend the 2 nd
•
OMICS Group invites all the participants across the globe to attend the 2 nd International
OMICS Group invites all the participants across the globe
to attend the 2 nd 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
o
Bi
os m
i
il
ars
i
n o
t
th
e
Gl
b
a
l Ph
armaceu ca
ti
l E
conomy s nce
i
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.
of pharmaceutical R&Ds are worried about patent issues with generic drugs and their molecular entities.
The criteria required in filing of biological drugs will be discussed by popular agencies and
The criteria required in filing of biological drugs will be discussed by popular agencies and
The criteria required in filing of biological drugs will be discussed by popular agencies and
The criteria required in filing of biological drugs will be discussed by popular agencies and
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
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.
and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biowaivers.
Biosimilars or Biologics are biological medical products made or derived from the active drug substance
Biosimilars or Biologics are biological medical products made or derived from the active drug substance
Biosimilars or Biologics are biological medical products made or derived from the active drug substance
Biosimilars or Biologics are biological medical products made or derived from the active drug substance
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
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.
severe health consequences. Countries like USA therefore are accepting only a few subsequent versions of biologics.
•
• BiowaiversBiowaivers Biowaivers are official waive off for a particular drug from the bioequivalence studies.
• BiowaiversBiowaivers Biowaivers are official waive off for a particular drug from the bioequivalence studies.
BiowaiversBiowaivers Biowaivers are official waive off for a particular drug from the bioequivalence studies. Generic
BiowaiversBiowaivers
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
gener c
i
d
rug w
ith th
a
t
o
f th
e or g na
i
i
l
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.
Standard guidelines have been framed in most of the USA and EU countries as for as
•
• BiosimilarsBiosimilars--20132013 OMICS Group announces the 2nd International Conference and Exhibition on Biowaivers
• BiosimilarsBiosimilars--20132013 OMICS Group announces the 2nd International Conference and Exhibition on Biowaivers
BiosimilarsBiosimilars--20132013 OMICS Group announces the 2nd International Conference and Exhibition on Biowaivers
BiosimilarsBiosimilars--20132013
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
w
h en
th
e
Cli
n ca
i
l t i
r a s an
l
d i
ssues re a e
l
t
d t
o gener c
i
d
rugs are un er
d
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.
and speeches by esteemed members of the keynote forum. The presentations and talks are divided into
• •
• • EminentEminent SpeakersSpeakers atat thethe eventevent Michael Retsky, Harvard School of Public Health, USA
• • EminentEminent SpeakersSpeakers atat thethe eventevent Michael Retsky, Harvard School of Public Health, USA
EminentEminent SpeakersSpeakers atat thethe eventevent Michael Retsky, Harvard School of Public Health, USA Sinerik
EminentEminent SpeakersSpeakers atat thethe eventevent
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
•
• • • •
• • • • MajorMajor TracksTracks forfor thethe discussiondiscussion Challenges and Regulatory Approach for
• • • • MajorMajor TracksTracks forfor thethe discussiondiscussion Challenges and Regulatory Approach for
MajorMajor TracksTracks forfor thethe discussiondiscussion Challenges and Regulatory Approach for Biosimilars Emerging
MajorMajor TracksTracks forfor thethe discussiondiscussion
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
• • •
•
• • Biosimilars-2013 will provide an excellent and global opportunity to the scientists, partners and pharma
•
Biosimilars-2013 will provide an excellent and global opportunity to the scientists, partners and pharma leaders
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/
on Biosimilars-2013 conference, please visit: http://www.omicsgroup.com/conferences/biowaiv ers-biosimilars-2013/
ForFor furtherfurther detailsdetails contactcontact Badoni Victor Biosimilars-2013 Organizing Committee Pharmaceutical
ForFor furtherfurther detailsdetails contactcontact Badoni Victor Biosimilars-2013 Organizing Committee Pharmaceutical
ForFor furtherfurther detailsdetails contactcontact Badoni Victor Biosimilars-2013 Organizing Committee Pharmaceutical
ForFor furtherfurther detailsdetails contactcontact Badoni Victor Biosimilars-2013 Organizing Committee Pharmaceutical
ForFor furtherfurther detailsdetails contactcontact
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
Canada) Email: biosimilars2013@omicsonline.net Badoni Victor OMICS Group Incorporation +1- 650-268-9744 email us here