Clayton Pharmaceuticals is coming for AbbVie. Having shown bioequivalence using bioassays, Clayton won FDA approval of its sucralfate oral suspension with competitive generic therapy (CGT) designation.
Pennsylvania-based Clayton hailed the FDA approval as “a paradigm shift in how complex generic drug products can be commercialized without the need for expensive, long-drawn, and sometimes non-viable clinical studies.” The development program used 12 bioassays to track “the product's postulated clinical interactions using in vitro biology” and thereby generate the data required by the FDA.
Clayton pulled together a team of companies to support the novel development program, with VistaPharm and Neuheit Pharma Technologies collaborating on the project and Absorption Systems and CellPort Software providing testing and analytics support.
The collaborators developed a generic version of the Carafate oral suspension sold by AbbVie. Carafate, which is also available in tablet form, is used to treat intestinal ulcers. Amneal Pharmaceuticals won FDA approval for a generic version of the oral suspension form of the medicine in 2019, but the agency still designated Clayton’s challenger as a CGT.
Congress created the CGT pathway through the FDA Reauthorization Act of 2017 to enable the agency to support products that target markets with “inadequate generic competition.” FDA can expedite the review of filings for CGT-designated products.
While gearing up to challenge for the sucralfate oral suspension market, which was worth $188.5 million last year, Clayton is also looking forward to applying the experience it gained on the novel development program to other complex products.
“This ANDA approval using well‑designed, scientifically sound in vitro bioassays endorses the use of novel approaches to demonstrate product bioequivalence. We are buoyed by the approval of this product and ready to solve the bioequivalence challenges for the next set of complex products,” Clayton CEO Sid Bhoopathy said in a statement.