Risk Assessment: A Pragmatic Approach To Develop Biosimilars | 22433
Journal of Bioanalysis & Biomedicine
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Therapeutic proteins and antibodies are one of the most important and rapidly growing segments of the pharmaceutical
industry. By 2016, yearly spending on brand biologics will reach $60 billion. But affordability of these life-saving drugs is
a challenge specifically in the developing world. There is a pragmatic solution on the horizon for safe, affordable, biosimilar
versions of these critical therapies. Biosimilars have been proved safe and efficacious in Europe for last seven years but in USA
the guidelines from US FDA to develop biosimilars is still awaited. As we know the genesis of Biosimilars is providing cheap,
affordable drugs for the masses, specifically in emerging markets where affordability of critical drugs is a major concern. In
this presentation, the author will focus on how to design the development in a cost effective way keeping a close watch on
Critical Quality Attributes (CQAs) of the drug. What and how much is required to establish the Biosimilarity of the drug is
more important. There is a huge improvement in assays available during the development of innovator molecules and assays
available now. It is now possible to accurately quantitate the chemical status of each residue in a protein molecule and measure
minute structural variance using various orthogonal approaches. On top of that the relevance and extent of clinic trails for
innovators and for biosimilars will be discussed too.
Harish Shandilya is heading Biocharacterization of therapeutic proteins at INTAS Biopharmaceuticals Ltd., Ahmedabad. He is working with INTAS for last 7
years now. Prior to this assignment, he has developed clones for many biotherapeutic proteins. He is a molecular biologist by training and has worked at various
prestigious institutions in India and abroad. He did his Postdoctoral work at Vanderbilt University Medical Center, Nashville, USA. Before joining Intas, he was
associated with University of Pittsburgh, USA. He has done his PhD degree (1999) from India. He has published more than 20 research papers in reputed journals.
He has experience of coordinating multiple Biosimilar product development programs for domestic and regulated market projects.
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