Biosimilars -New Horizon of the Generic Drugs
Keywords:Biosimilars, generic, patent, regulatory, comparability
Biosimilars (or Biologics) are the fastest growing segment of the pharmaceutical market with about 30 odd branded molecules sales in excess of $50 billion facing patent expirations. However, development of biosimilars is not an easy cake walk and linked with many challenges either due to its complexity in development or regulatory concerns or manufacturing challenges etc. Biosimilars can be expensive to manufacture and fully characterize in comparison with the innovative biomolecule. Furthermore, the complexity involved in carrying out the pharmacology and toxicology studies, design and execution of clinical studies would needless to say involve time and lot of investment. Unlike small molecule generics, the process of developing and commercialization of a biosimilar can take up to 7 years or longer. Years back, when the innovative protein molecule had been developed, product criteria had been spelt out as per one’s own requirement. However, when a biosimilar is being developed, the product and process so developed would have to comply with more stringent regulatory requirements. Development of biosimilars would require a lot amount of analytical, physical and clinical evidence to demonstrate high similarity to the innovator drug.
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