An FDA advisory panel made history last week when, for the first time, it recommended approval of a biosimilar drug, which is a highly similar version of a biologic therapeutic product. The FDA Oncologic Drugs Advisory Committee unanimously voted to recommend that the Agency approve a biosimilar cancer drug for all five indications in the application. The vote is a significant step to FDA approval and subsequent marketing of the first biosimilar in the United States. Markets outside the United States have been quicker to establish regulations for approving biosimilars, and the biosimilar at issue is already sold in more than 40 countries. Although FDA may not consider drug prices when making approval decision, cost is clearly an important issue for patients, who are advocating for the drug's approval to lower treatment costs. According to a Rand Corporation analysis, biosimilars could offer a cost savings of approximately $44 billion over the next 10 years.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.