3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product.

However, that lack of FDA guidance on interchangeability (and the absence of such a designation in the EU, where biosimilars have been used more widely and for a longer period of time, resulting in significant cost savings) has not stopped more than 20 states from enacting legislation that would prohibit pharmacists from switching patients from a biologic to a non-interchangeable biosimilar without a doctor’s consent.

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