FDA Grants Ruconest Twelve-Year Reference Product Exclusivity

The U.S. Food and Drug Administration (FDA) has granted 12 years of exclusivity to Ruconest® (C1 esterase inhibitor

[recombinant]) 50 IU/kg. The determination of exclusivity ensures that FDA will not approve before July 16, 2026 any applications for biosimilars of Ruconest— i.e. applications for recombinant C1 esterase inhibitors referencing Ruconest submitted under section 351(k) of the Public Health Service Act under the framework established by the Biologics Price Competition and Innovation Act of 2009.

Ruconest was approved by the FDA on July 16, 2014, for the treatment of acute angioedema attacks in adult and adolescent patients with HAE. Effectiveness was not established in HAE patients with laryngeal attacks.

Under the Biologics Price Competition and Innovation Act of 2009, exclusivity for licensed biologics— like Ruconest— can be granted for a 12-year period from the date of first licensure of the product.

“We are pleased the anticipated exclusivity for Ruconest has been formally granted,” said Deb Jorn, Executive Vice President/Company Group Chairman, Valeant Pharmaceuticals. “The response to Ruconest has been positive since its launch in November 2014 and we look forward to continued growth.”

Sijmen de Vries, the CEO of Pharming Group NV, commented: “Pharming strived to make Ruconest available to the HAE patient community in the US, because we were aware of the great value

and benefits that Ruconest could provide to patients. That the FDA granted 12 year exclusivity for Ruconest reinforces this long-standing commitment and we are excited to continue to work closely with Salix to ensure patients in the US have access to Ruconest.”

While Pharming Group NV is developing innovative products for the treatment of unmet medical needs, Salix Pharmaceuticals, a division of Valeant Pharmaceuticals International, Inc., develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases.
(Source: Pharming)