Bad news for AstraZeneca: FDA lays out roadmap for would-be Symbicort copycats

Courtesy of AstraZeneca

The FDA has issued AstraZeneca's ($AZN) least favorite form of draft guidance--the kind that helps other drugmakers develop copies of a blockbuster seller.

Regulators have published bioequivalence guidelines for AstraZeneca's respiratory heavyweight Symbicort, giving generics makers a lift in their quest to bag a piece of the med's revenues. UBS analyst Alexandra Hauber says the prospect of knockoffs hitting this decade is now more likely, jeopardizing 2020 sales estimates of $1.8 billion for the drug, Reuters reports.

The way Hauber sees it, the worst-case scenario involves a mid-2018 generic launch, which would cut down valuation by about £3 ($4.69) per share, or about 5%. The drug brought in $3.8 billion for AstraZeneca last year.

AstraZeneca isn't the first maker of respiratory drugs to see its competitors helped by the FDA. In September 2013, the agency did the same with GlaxoSmithKline's ($GSK) hard-to-copy Advair, whose Diskus inhaler technology had been confounding would-be copycats for years.

With the British drugmakers already in a respiratory pricing war--negotiating discounts that have helped them take turns knocking each another off preferred formularies at the country's largest pharmacy benefits managers--stateside generics are the last things either company needs. Advair's U.S. sales are currently in a tailspin because of the payer tactics, plunging 22% in the first quarter of this year.

But with copies of Advair--sold as Seretide outside the U.S.--and Symbicort already floating around in Europe, their emergence in the U.S. is inevitable. Mylan's ($MYL) Sirdupla earlier this month joined a growing list of Advair copycats, including Novartis' ($NVS) AirFluSal Forspiro and a version from India's Cipla. And Teva ($TEVA) is busy rolling out its DuoResp Spiromax, a Symbicort stand-in, market by market on the continent.

AstraZeneca isn't ready to cede its leadership position in respiratory, though. CEO Pascal Soriot has tagged the field as one of 6 key growth areas that'll help the company deliver on its ambitious revenue goals. To that end, AZ recently inked a couple deals: In February, it agreed to fork over $600 million for a pair of Actavis lung meds, after picking up Almirall's respiratory portfolio a few months prior.

- get more from Reuters
- see the draft guidance (PDF)

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