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. 

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
  • Biosimilar monoclonal antibodies
  • Economic aspect towards biosimilars
  • Advertising, promotion and labeling essentials
  • Drug Safety essentials
  • Early clinical development essentials
  • Late clinical development essentials
  • Current concepts of drugs and biologics
  • Unique considerations for biologics
  • Comparability for Biologics

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