Drugs

FDA Drug to Biologic Transition Guidance

A 3/14 FDA draft guidance explains how the agency will implement Biologics Price Competition and Innovation Act (BPCIA) provisions for moving protein products currently approved under the drug statute to the biologics system. The BPCIA requires that as of 3/23/20, all NDAs and ANDAs for protein products will be “deemed to be a license” under Section 351 of the Public Health Service Act. The draft is FDA’s first interpretive statement on the “deemed to be a license” provision.

Four Hogan Lovells attorneys write in an online post that the most significant aspect of the draft is the position the agency takes on exclusivity and patents for these transitional products. It also addresses the situation in which a drug application for a transition product may be pending at FDA as of the 3/23/20 deadline.

As of the deadline date, the post says, any approved drug applications for products meeting the definition of a biological product will no longer exist as NDAs or ANDAs. Instead, they will immediately be replaced by approved BLAs. According to the attorneys, the agency does not say how it will determine whether an approved NDA will be deemed to be a 351(a) biologic or a 351(k) biosimilar. The attorneys say that decision has significant implications for protein products approved under 505(b)(2) NDAs.

FDA also emphasizes in the draft, the post says, that the statutory transition provision only accounts for approved drug applications. The attorneys say that FDA reads this to mean that any NDA or ANDA for a biological product that is either pending or tentatively approved as of the deadline will effectively be deemed as withdrawn. The sponsor would have to resubmit the application under 351(a) or 351(k), potentially imposing a disruption for the sponsor.

Orange Book listings including product patents and exclusivities will be terminated as of the transition date, except for orphan drug exclusivity. The attorneys say that provision means that any existing Waxman-Hatch exclusivity and any remaining 30-month stay time “will immediately be extinguished and, in FDA’s view, forever lost.” The agency also reportedly makes clear in the guidance that it does not believe that a “deemed licensed” transition product is entitled to receive any amount of the 12-year exclusivity period allowed under Section 351 for reference biological products.

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