With Biogen launch, the U.K. has two anti-TNF biosims. In the U.S.? Not soon, analyst says

Engineers at the Samsung Bioepis R&D Center. Photo courtesy of Business Wire.

Biogen rolled out its Remicade biosimilar, Flixabi, in the U.K. this week, thus becoming the first drugmaker to market two anti-TNF biosims in the country.

But don’t expect the company--or any other, for that matter--to pull off a similar feat in the U.S. anytime soon.

Biogen’s Flixabi follows its biosimilar version of Amgen’s anti-TNF med Enbrel, dubbed Benepali, onto the market. Both drugs were developed by Samsung Bioepis, the Cambridge, MA-based biotech’s joint venture with Korea’s Samsung.

For Remicade (infliximab), marketed by Merck & Co. in Europe, it’s yet another competitor to erode sales. Celltrion and partner Hospira each sell Remicade copies in the region, and Merck’s brand sales have suffered more than previously expected.

For Biogen, it’s a milestone for a biosimilar development effort that extends into multiple copycats to the world’s top-selling biologic drugs. Samsung Bioepis has advanced biosim versions of Sanofi's blockbuster insulin Lantus (insulin glargine), AbbVie's anti-TNF treatment Humira (adalimumab), Roche's breast cancer drug Herceptin (trastuzumab) and its multicancer drug Avastin (bevacizumab)--and it has another 7 molecules in early stages of development. The FDA accepted Samsung Bioepis’ application for the infliximab biosim in May.

For makers of anti-TNF drugs, which treat inflammatory conditions such as rheumatoid arthritis and psoriasis, the latest launch is another warning bell. But the key U.S. market is where the biggest sales are to be lost--or won, depending on your point of view. The category accounted for about $20 billion in U.S. sales last year.

Regulators are moving quickly on that front, too. Pfizer’s Hospira unit won U.S. FDA approval for its Remicade biosimilar just last month. Novartis’ Sandoz nabbed FDA panel backing for its Enbrel biosim, while Amgen got similar backing for its knockoff version of AbbVie’s Humira, the dominant drug in the category.

But patent lawsuits will keep those launches at bay for some time, at least for the Enbrel and Humira biosimilars. As Leerink Partners analyst Geoffrey Porges points out in a Wednesday investor note, fights over the patents on Remicade, Enbrel and Humira are all still raging. And though Remicade’s patent case is weak enough to encourage Pfizer to move ahead with an “at risk” launch of its Inflectra biosim next month, the outstanding IP on the other two meds is likely to give Sandoz and Amgen pause.

“The path for a biosimilar [Remicade] is nearer and clearer due to the recent invalidation of J&J’s ‘471 patent,” Porges wrote. “In this case, it seems likely that Pfizer will go ahead and launch its biosimilar infliximab” in the fourth quarter.

J&J is appealing the district court decision that struck down that ‘471 patent, but Pfizer most likely sees “the risk/reward scenario” falling in its favor, Porges figures.

As for the Enbrel and Humira protections? They’re likely strong enough--or the cases against them uncertain enough--to forestall a biosim launch. AbbVie just sued Amgen last month to protect Humira from the Big Biotech's biosim. And launching a biosim before an IP battle is resolved puts copycat drugmakers on the hook for restitution and damages if the patents stand. Unless and until upcoming court dates and filings offer enough encouragement, the launches are likely to wait.

“Given the size of these products and the financial stakes, this seems unlikely to us, at least before there is some resolution of the patent landscape on a molecule-by-molecule basis,” Porges figures. “We do not believe a biosimilar [Enbrel] or [Humira] will launch ‘at-risk’ earlier than 2018.”

Special Report: The top 20 drugs in 2020 by worldwide sales - Humira - Enbrel - Remicade

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