New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers

This may be good news for partners Mylan and Biocon: Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. However, the timing for passage of these bills is questionable.

The Senate’s Affordable Insulins Approval Now Act (S.2103), a bipartisan bill that was introduced by Senator Richard J. Durbin (D-IL) in mid-July, has 13 cosponsors to date. It was referred to the Committee on Health, Education, Labor, and Pensions, where it awaits review.

Insulin transition
Senator Richard J. Durbin

Under this bill, a pharmaceutical company may file a 505(b)2 application for an insulin product before January 1, 2020 and still be evaluated via the abbreviated new drug approval pathway beyond the March 20, 2020 transition date. These filings are regulated under the Food, Drug, and Cosmetic Act, which governs the approval of nonbiologic drugs.

If S.2103 is passed, Mylan/Biocon, which received a complete response letter from the Food and Drug Administration September 25 for its follow-on insulin product, would not have to refile for approval under the 351(k) pathway as a biosimilar. Under the terms of S.2103, the insulin would only be transitioned to biologic status and regulated under the Public Health Services Act once approval has been obtained (regardless of when that occurred).

A separate House bill (HR.4244) was introduced in September by Representative Michael Kelly (R-PA). This proposal takes a different approach towards encouraging insulin copy development—completely removing the mandate to transition insulin copies to the 351(k) approval pathway. This bill, which has been referred to the House Committee on Energy and Commerce, does not have any cosponsors at present. Under Representative Kelly’s proposal, insulin copies would be carved out and continue to be regulated under section 505 of the FD&C Act.

The timing and current status of these bills make it seem unlikely they would be signed into law before the transition date of March 20, 2020. However, it is possible that actions of this type can be attached to other legislation that is further along. Companies like Mylan and Biocon certainly hope so, otherwise valuable time (having to wait until March 24, 2021 to apply as a biosimilar) will be lost in this regulatory “dead zone.”

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