College of Pharmacy
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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.
- "Biosimilars" are approved through a new pathway, called 351(k), where PK/PD and immunogenicity data are evaluated along with data proving biosimilarity.
- Biosimilarity means they are highly similar to the available reference biologic product and there is no clinically meaningful difference between the two.
- 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.
- 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.