With the news last week that the Assembly in the bellwether state of California passed a bill – S.B. 598 – by a 58-4 vote concerning the substitution of biosimilar and interchangeable biosimilar products for their brand-name reference product counterparts, and with bills currently passed, failed or pending in other states (and the likelihood that legislation will continue to be pushed in several states for some time to come), we thought it was high time to put together a new scorecard – the Biosimilars State Legislation Scorecard – to keep tabs on such legislation. Once we get a chance, we’ll add a direct link to this new scorecard, along with any others we have created (such as our popular Generic Drug Labeling Carve-Out Citizen Petition Scorecard) to the FDA Law Blog website where our various trackers (Citizen Petition Tracker, Legislation Tracker, 180-Day Exclusivity Tracker, and REMS Tracker) are linked to as well. We’ll update the scorecards periodically and post separately on items that are particularly newsworthy.
State legislation addressing biosimilar substitution issues has been particularly controversial. Indeed, after the California Assembly’s passage of S.B. 598, an FDA spokesperson reiterated concerns previously expressed by FDA Commissioner Margaret Hamburg that “[e]fforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower-cost treatments.”
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