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HelixTalk Episode #56 - Entering the era of biosimilars!

Date posted: February 7, 2017, 6:00 am

In this episode, we discuss the new FDA categorizations of biosimilars, the legal implications of biologic/biosimilar prescriptions, and the new "follow-on" approval pathway of Basaglar, a new insulin glargine U-100 product.


Key Concepts

  1. "Biosimilars" are approved through a new pathway, called 351(k), where PK/PD and immunogenicity data are evaluated along with data proving biosimilarity.
  2. Biosimilarity means they are highly similar to the available reference biologic product and there is no clinically meaningful difference between the two. 
  3. Prescription writing requirements and state specific laws should be considered when filling a prescription for a biologic vs. biosimilar medication. Patient and provider education should occur prior to such a substitution. 
  4. Basaglar, approved through the 505(b)(2) small molecule drug pathway, is not a biosimilar but a ‘follow-on’ insulin product that is similar to insulin glargine. It can provide 15-20% lower cost compared to Lantus product.