Embattled pharmaceutical company Valeant, whose leading product Xifaxan has already attracted a number of problems, may experience increased competition for the drug earlier than it was anticipating, courtesy of the Food and Drug Administration (FDA). Last Friday, US regulators listed a new set of guidance on the requirements for generics manufacturers to demonstrate bioequivalence to Xifaxan, designed to remove some of the barriers to bringing these drugs to market, and hence increase competition. In a guidance note to clients, Wells Fargo analyst David Maris explained that in future the FDA will no longer require companies to carry out a bioequivalence study with clinical endpoints before accepting bioequivalence, which is likely to make the generic production process much easier, cheaper and less risky.
According to Maris, the change is likely to make it possible for many more companies to bring forward their generic versions of the drug. He believes that, as a result of the revised guidance, there is significantly more chance of generic competition entering the market by 2023 or even earlier. This new FDA guidance could be seen as a snub to Valeant, following last year’s citizen petition from Valeant’s subsidiary, Salix, which markets Xifaxan. The petition to the FDA asked the regulators to reject generic applications that did not include evidence to show that the generic drug has the same polymorph profile as Xifaxan.
If the revised FDA rules do lead to earlier generic competition to Xifaxan, Valeant could find itself under increasing pressure. Its GI portfolio is already struggling, with sales of Xifaxan and other GI products short of where the market expected them to be. That trend led to the company rolling out revamped marketing plans following the collapse of a deal with Japan’s Takeda. The company has also recently lost over fifty representatives, which has further exacerbated their ongoing turnover problems.
Valeant isn’t the only operator in the IBS-D market to be struggling. Last week, the FDA stepped in with a warning that Xifaxan’s leading rival, Viberzi, sold by Allergan, could lead to pancreatitis deaths in patients without gallbladders.
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