Biologics and Biosimilars

Large, complex pharmaceuticals called biologics are made from living things and are used to treat a variety of ailments, such as cancer, autoimmune diseases, and chronic illnesses. They consist of gene treatments, vaccinations, and monoclonal antibodies. When the patent on the original biologic expires, biosimilars—very identical versions of the biologic—are designed to provide more economical treatment options. Biosimilars, in contrast to small-molecule generics, are required to exhibit comparable safety, efficacy, and quality to the reference biologic; yet, because biologics are inherently variable, they are not interchangeable. The creation of biosimilars offers chances and difficulties for increasing access to necessary treatments while upholding strict criteria for patient safety and effectiveness.

  • Immunogenicity
  • Comparative Clinical Trials
  • Manufacturing and Quality Control

  • Immunogenicity
  • Comparative clinical trials
  • Manufacturing and quality control

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