Challenges in Developing Biosimilars

The biosimilars market is set to expand over the next decade and beyond as a result of two major factors: the impending patent expires on blockbuster biologics and the financial crisis that is driving payers to push for wider adoption of biosimilars to manage the escalating costs of healthcare. Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved. 

  • Equivalence of complex drug products
  • Bioanalytical Challenges
  • Current concepts of drugs and biologics
  • Unique considerations for biologics
  • Early clinical development essentials
  • Late clinical development essentials
  • Drug Safety essentials
  • Advertising and promotion essentials
  • Comparability for Biologics
  • Economic aspect towards biosimilars
  • Biosimilar monoclonal antibodies
  • Consideration of biowaiver extensions for BCS class III drugs

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