Current Challenges in Developing Biosimilars

Biosimilars are the generic version of Biologic drugs. The former is a kindred copy of the reference product with very comparable efficacy, potency and pharmacology with the later. However, the development of a biosimilar product is highly challenging in terms of lead generation, product development, establishing the same pharmacology, formulation and finally gaining the approval from concerned regulatory bodies. Moreover with the rising demand for QbD products and increased patient affordability and accessibility the development of biosimilars in a cost effective becomes yet more challenging.

  • Quality by Design for Biologics and Biosimilars
  • Early clinical development essentials
  • Late clinical development essentials
  • Drug safety essentials
  • Comparability for biologics
  • Unique considerations for biologics
  • Advertising, promotion and labeling essentials
  • Implimentation of the BPCI Act
  • Biopharmaceuticals development
  • Biologics in genetic disorders

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