FDA advances two more Herceptin biosims—this time from Amgen and Teva—as Roche braces for impact

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The FDA has now accepted three applications for copies of Roche's Herceptin, which last year generated $7.02 billion in global sales.

Herceptin biosimilars are coming for Roche in the U.S., and Monday, a pair of them got one big step closer.

Amgen-Allergan and Teva-Celltrion duos each said that regulators had accepted regulatory filings for their respective candidates, and Amgen R&D chief Sean Harper dubbed the event “an exciting milestone.”

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But it wasn’t so exciting for Roche, whose elderly cancer blockbusters are about to face a full-on assault. The FDA acceptances follow just a couple of weeks after a advisory panel twofer that unanimously recommended approval of an already-filed Herceptin copy from Mylan and Biocon and an Amgen version of Roche’s Avastin; The agency has promised Mylan’s team a decision by Sept. 3, and all three Herceptin copycat pairs have already filed applications in Europe, too.

The Swiss drugmaker’s execs didn’t seem all that concerned on last week’s Q2 earnings call, though, instead putting the emphasis on its 16 FDA breakthrough designations that’ll speed new approvals and indications. “This is industry leading and it's this kind of innovation which will enable us to offset the entry of biosimilars, which we expect increasingly so over the next years,” CEO Severin Schwan told investors.

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The company also raised its outlook for 2017 despite the forthcoming threats thanks to a booming performance from new multiple sclerosis med Ocrevus. In its first quarter on the market, the med pumped out $200 million in sales, thanks in part to the big discount Roche offered over competing meds.

Still, $7.02 billion in worldwide 2016 Herceptin sales is a lot to have riding on the line when biosims arriveand that’s not to mention the matching haul Avastin posted last year.

But one benefit Roche sees to picking up some Herceptin rivals? Once they force down the cost of the med, it’ll make the economics of a Perjeta-Herceptin breast-cancer combodata from which hasn’t exactly wowed investors“even more favorable,” pharma chief Daniel O’Day said on the Q2 call.