Current Challenges in Developing Biosimilars

For the development of biological calls many changes may occur. Concepts of biologics with considerations at initial stages, clinical developments are essential at early. For the successful development of biologics follow on proper scientific and strategic approaches are need. Most probably, the drug safety factors and labelling requirements are the overcoming challenges and important in continue of late clinical steps. And now it is much required to develop a drug product in according to quality by design.

 

 

  • Current concepts of drugs and biologics
  • Cancer therapeutics development
  • Drug safety essentials
  • Biopharmaceuticals development
  • Advertising, promotion and labeling essentials
  • Unique considerations for biologics
  • Late clinical development essentials

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