Look out, Amgen: Novartis wins second FDA biosim approval, this time for Enbrel copy

Put another tally in Novartis’ biosimilar win column. The company’s Sandoz generics unit has another FDA approval in hand, this time for its copy of Amgen’s anti-TNF blockbuster Enbrel.

On Tuesday afternoon, the Swiss drugmaker announced that regulators had given the thumbs-up to the knockoff, Erelzi, greenlighting the product in all of Enbrel’s indications--including rheumatoid arthritis, plaque psoriasis and psoriatic arthritis. With the decision, Sandoz is now one step closer to grabbing a piece of the $5.10 billion in U.S. sales that Enbrel collected last year.

The move is no surprise, given the 20-0 backing an FDA advisory committee gave the candidate last month. Although the agency doesn’t always follow panel recommendations, it typically does.

The go-ahead puts Novartis in position to pad its lead in the U.S. biosimilars market, which it first took last September when it rolled out Zarxio, a copy of Amgen’s Neupogen. Since then, Pfizer has won U.S. regulators’ favor for its version of Johnson & Johnson’s Remicade, but that product has yet to launch.

It may still be awhile before Erelzi actually sees the market, though. This March, Amgen slapped Sandoz with a patent infringement suit, claiming the generics giant was “piggybacking on the fruits” of its “trailblazing efforts” with Enbrel and asking the U.S. District Court for the District of New Jersey to grant an injunction to block Erelzi sales.

Amgen, for one, would like to keep Sandoz at bay for as long as possible--especially with Neupogen already under attack. And meanwhile, to help fill the gap, it’s hard at work on a biosimilar program of its own. Its iteration of AbbVie best-seller Humira--dubbed ABP 501--also scored a unanimous “yes” recommendation from panel experts, picking up 26-0 victory one day before Sandoz’s unanimous Erelzi vote.

- read Novartis' release

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