Mylan announced Monday that its US subsidiary will introduce the first generic EpiPen (epinephrine) auto-injector at a list price of $300 per two-pack carton, representing a discount of more than 50 percent to its list price for the branded medicine. The company, which expects to launch the generic allergy treatment "in several weeks, pending completion of labelling revisions," indicated that it also plans to continue marketing branded EpiPen.
"We understand the deep frustration and concerns associated with the cost of EpiPen to the patient," remarked Mylan chief executive Heather Bresch, who described the decision to offer a generic version of the therapy as "an extraordinary commercial response." Bresch explained that "the complexity and opaqueness of today's branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, [is why Mylan decided] that bypassing the brand system in this case and offering an additional alternative was the best option…[for] a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient."
Last week, Mylan unveiled plans to improve access to EpiPen, including covering patients' insurance out-of-pocket costs for the treatment up to $300, from $100 previously. The move came after US lawmakers asked Mylan to justify increases on the product, whose price has risen from $100 in 2008, a year after it was acquired via the purchase of Merck KGaA's generics unit, to more than $600 this year.
Commenting on Mylan's decision to launch a generic version of EpiPen, Sanford C. Bernstein analyst Ronny Gal described the action as a "smart move" that would be "quite costly" for the drugmaker. Gal added that while the launch could reduce Mylan's overall revenue per epinephrine auto-injector prescription by approximately 25 percent, the decision could alleviate downward pressure on the company's stock due to the controversy.
Bernstein analysts recently suggested that the pricing issue could compel the FDA to accelerate the approval of a generic competitor for EpiPen. In March, Teva said the launch of its generic version of the treatment would be delayed until at least next year after the FDA had identified "major deficiencies" in its application. Meanwhile, Sanofi issued a voluntary recall of its non-generic epinephrine injection Auvi-Q last October due to reports of potentially "inaccurate dosage delivery" in the US and Canada. The company has since announced plans to return all US and Canadian rights for Auvi-Q to kaléo this year.
For related analysis, see Spotlight On: Mylan's EpiPen saga could help shine light on murky dealings within supply chain. See also ViewPoints: Mylan scrutinised and Spotlight On: Mylan may be courting danger with EpiPen pricing strategy.
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