Biosimilars Congress India 2017, August 8 – 9, in Hyderabad where professionals discuss strategies for biosimilar product development Indian Pharmaceutical companies have started to look at biosimilars as a lucrative sector owing to the recent regulatory approvals and revenue generating opportunities.
Manufacturing biosimilar products is huge challenge, due to the sheer complexity and structure of its molecules and a smallest change in the manufacturing process can cause substantial changes in the final drug’s efficacy and safety. Hence, the biopharma companies strive hard to develop failure free procedures to comply with stringent regulatory guidelines.
Biosimilar pathways are still evolving across the world and the major issues pharma companies face is with respect to demonstrating biosimilarity to the reference product. Considering these challenges, CPhI India is launching the Biosimilars Congress India 2017 scheduled from 8 – 9 August 2017 in Hyderabad.
Key topics to be discussed are
- Regulatory Expectations of authorities for regulated and emerging markets
- Method development and validation for Biosimilars
- Demonstrating biosimilarity with respect to reference drug
- Characterisation of Biosimilar molecules
- Eliminating product and process impurities
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