Global Biosimilars Market - DOC

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					                       Biosimilars – Big opportunity but Bigger hurdles


Bangalore, India June 3rd 2010: Bangalore INDIA BIO 2010, India's premier Biotechnology
event held a session on “Successfully Negotiating the Biosimilars Landscape” on Day 2. The
session was chaired by Dr. P.M. Murali - Managing Director , Evolva Biotech Private Limited ., the
speakers: were Dr. K.V. Subramaniam - President & CEO , Reliance Life Sciences , Dr. K.K.
Tripathi -Adviser/Scientist „G‟ and Member Secretary RCGM , Department of Biotechnology ,
Ministry of Science & Technology Government of India , Dr. Eric Grund - Senior Director,
Biopharma Applications , GE Life Sciences and Dr K V Subramaniam - President & CEO,
Reliance Life Science

Dr. K.V. Subramaniam - President & CEO , Reliance Life Sciences, said, "the global biosimilars
opportunity is significant, valued at US $ 70 billion covering 25 products. An integrated biosimilars
initiative requires several competencies working seamlessly across the value chain hence
competencies required. Competitive advantages in biosimilars will hinge on quality, cost,
timelines, regulated market access.”

“The technology hurdles, significant cost and regularity pathway in development markets are
major challenges faced. The right talent and partnership play a key role in addressing challenges
in biosimilars.” he said.

“Reliance life science is building a research led, diverse and integrated biotechnology business.
They have 5 biosimilars in the semi – regulated market and 17 biosimilars under development.
The biosimilars landscape is attractive but marked by several formidable challenges.” he added.

Dr. K.K. Tripathi - Adviser/Scientist 'G‟ and Member Secretary RCGM, said, “Biopharmaceutical
term can be used widely and is hardly defined by users over 4 million entries on google, involve
use of biotechnology and pharmaceutical compared to drugs. Biopharma is complex on how we
think of, define, name and regulate these products. biopharma industry is more than 25 years old
and has 350 products in the market.”

Dr. Eric Grund Senior Director, Biopharma Applications, GE life sciences, said, “As The
Regulatory pathway for biosimilars in Europe and USA becomes clearer manufacturing of these
products still remain challenging. There is a pressure in increasing the efficiency and there are
market uncertainties. Although using disposables is a popular to address such issues there are
examples applicable to existing facilities such as straight-through processing and continuous
chromatographic capture of a monoclonal anti body. In both the cases there is high level of
process control and is critical for implementation.”

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