• Corpus ID: 152507033

Understanding and Incentivizing Biosimilars

  title={Understanding and Incentivizing Biosimilars},
  author={Jason Kanter and Robin C Feldman},
  journal={Hastings Law Journal},
Congress recently passed the Biosimilars Act in an attempt to replicate the success that generic small molecule drugs have enjoyed under the Hatch-Waxman Act. The Biosimilars Act provides a pathway for biosimilars to achieve quicker and less expensive FDA approval than what is required for a new biopharmaceutical. There is, however, greater uncertainty and cost associated with achieving the coveted biosimilarity status. This reflects the complex production methods of biopharmaceuticals, along… 

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