Where’s The Suffix? Valeant’s Siliq Approved Without Four-Letter Identifier

The US FDA gave its blessing to Valeant Pharmaceuticals International Inc.'s psoriasis treatment Siliq (brodalumab), but without a four-letter suffix the agency said it would require for novel biologics and biosimilars.

A monoclonal antibody, brodalumab was approved Feb. 15 for the treatment of adults with moderate to severe plaque psoriasis. The approval comes with strict regulatory safeguards, including a Risk Evaluation and Mitigation Strategy (REMS) and a boxed warning for suicidal ideation and behavior. (Also see "US FDA Approval Of Valeant’s Siliq Comes With REMS, Boxed Warning" - Pink Sheet, 16 Feb, 2017.)

Brodalumab is the first novel biologic approved since FDA’s Jan. 12 release of a final guidance on nonproprietary naming of biologic products. The final document retained FDA’s August 2015 draft proposal to require that distinguishable, four-letter suffixes devoid of meaning be added to the nonproprietary names of all currently approved and future biosimilars, novel biologics and related products. (Also see "Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’" - Pink Sheet, 12 Jan, 2017.)

It appears FDA is awaiting OMB approval before imposing the suffix requirement for novel products.

The agency concluded distinguishable suffixes are required to facilitate pharmacovigilance and accurate identification by prescribers and patients, and to help minimize inadvertent substitution of products that have not been deemed interchangeable.

Since release of the August 2015 draft naming guidance, FDA has approved three biosimilars with distinguishable suffixes but has yet to apply the new naming policy to novel products.

However, it was thought that brodalumab, which had a Feb. 16 user fee date, might be the first novel biologic approved with a distinguishable suffix given that the guidance was finalized more than a month earlier.

Can't Afford To Delay Approval …

An FDA spokesman tells the Pink Sheet that Siliq was approved without a suffix because the final guidance was issued "at a point in our review of the application that did not allow sufficient time for FDA to designate a proper name that includes a suffix as described in the guidance."

"In order to avoid delaying the approval of brodalumab and in the interest of public health, FDA licensed the biological product with a designated proper name that did not include a suffix," FDA says. "We intend to work with the application holder for this biological product to implement the naming convention described in the guidance."

… But Waiting On OMB?

It also appears that FDA is awaiting Office of Management and Budget (OMB) approval of the information collection under the final guidance before imposing the suffix requirement for novel products. FDA said it “will publish a notice in the Federal Register announcing OMB’s decision before implementing the information collection provisions of the guidance.”

However, some stakeholders have asked OMB to block the guidance’s implementation because the agency ignored the downstream costs of the new naming system. (Also see "FDA’s Burden Estimate On Biologic Naming Ignores Downstream Costs, Critics Say" - Pink Sheet, 16 Feb, 2017.)

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended brodalumab for approval at a July meeting. Panelists were split, however, on whether a potential suicidality signal warranted a mandatory postmarketing registry as part of a REMS or a voluntary program outside of a REMS. (Also see "Valeant's Siliq Clears FDA Panel But Faces Prospect Of Post-Marketing Registry" - Pink Sheet, 19 Jul, 2016.)

The application’s original user fee goal date was Nov. 16, but Valeant announced in its third quarter earnings report that the date had been pushed back three months to allow additional time to negotiate the REMS. (Also see "Valeant’s Brodalumab Delayed By FDA As REMS Is Negotiated" - Pink Sheet, 8 Nov, 2016.)