The INSULIN Act successfully passed out of the United States Senate Health, Education, Labor and Pensions Committee in July, by a vote of 17 to 5 and now heads to the full Senate floor for consideration. It’s a bill with potentially significant impact, as it would limit out-of-pocket insulin costs to $35 a month for people with private insurance. This is a cap that Medicare beneficiaries already have through an Inflation Reduction Act provision. The INSULIN Act would also establish a pilot grant program helping uninsured patients access affordable insulin at the $35 maximum.

Importantly, the bill also includes provisions to curb alleged abuses of Food and Drug Administration citizen petitions that can delay lower-cost generic and biosimilar market entry. Such petitions allow any individual or organization to request that the agency take, change, or refrain from implementing a specific administrative action. In the case of branded pharmaceuticals, shortly before a generic or biosimilar competitor is set to get FDA licensing, the manufacturer may file a citizen petition that raises concerns about the pending market entrant.

As a reminder, generics are medications that contain the same active pharmaceutical ingredients as brand-name drugs whose patents have expired. As bioequivalent entities, they’re considered therapeutically interchangeable with their branded counterparts. Biosimilars are similar to medicines made from living organisms called biologics. Like biologics, biosimilars go through rigorous testing before receiving FDA marketing authorization. They’re made from the same types of organic material and offer the same clinical benefits as their referenced originators.

Congress Takes Aim At Barriers To Drug Competition

Lawmakers have introduced a bill that would eliminate the redundant........

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