July 03, 2013
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Allergan to challenge proposed FDA bioequivalence guidelines

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The U.S. Food and Drug Administration issued new and revised bioequivalence guidelines that may expedite the review and approval of generic versions of cyclosporine ophthalmic suspension and other agents.

Allergan, manufacturer of Restasis (cyclosporine ophthalmic emulsion 0.05%), plans to inform the FDA of its disagreement with the guidelines, according to a company spokesperson.

The FDA guidelines may enable companies to base applications for generic drugs on laboratory studies and not in vivo clinical trials with living human subjects.

In a draft guidance document issued June 20, the FDA’s Center for Drug Evaluation and Research proposed bioequivalence recommendations for studies that support abbreviated new drug applications (ANDAs). A notice on the document’s issuance was published in the Federal Register on June 20.

The FDA is inviting public comment on the proposed guidelines until Aug. 19.

“If [FDA] determines that … an ANDA contains sufficient evidence that the proposed generic drug product is bioequivalent to its reference listed drug and the application meets the other requirements for approval, the FDA will approve the ANDA,” the FDA document said.

“Allergan believes the proposed in vitro measures for cyclosporine ophthalmic emulsion cannot predict clinical safety and efficacy, and thus cannot be used to establish bioequivalence. Allergan will provide this feedback to the FDA during the 60-day comment period and is reviewing all of our potential options, including filing a citizen petition, to ensure that the appropriate scientific considerations are evaluated,” Heather Katt, Allergan’s director of corporate affairs and public relations, told Ocular Surgery News.

The patent on Restasis is scheduled to expire in May 2014. The FDA approved Restasis in 2002.

“It will speed up submissions and approvals for generic versions of cyclosporine opthalmic suspension products,” Stephen King, an FDA spokesperson, told OSN. “This approach may impact the bioequivalence recommendations for other products.”

Other ophthalmic agents listed in the draft guidance include dexamethasone-tobramycin ophthalmic suspension and ointment.

The FDA first issued bioequivalence guidelines in 2010.

Comments may be submitted online at www.regulations.gov or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.