Novartis/Sandoz Biosimilar Erelzi OK'd; Covets Enbrel's US Sales
Novartis AG unit Sandoz Inc. won US approval of its biosimilar Erelzi, which is referenced on Amgen's tumor necrosis factor blocker Enbrel (etanercept). The product, however, currently is caught in a patent dispute, although a recent stipulation has provided some hope for a smoother path through the legal jungle than other biosimilars may face.
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With Celltrion shipping the first batch of its biosimilar Inflectra (infliximab-dyyb) and a stipulation agreement with Johnson & Johnson, Pfizer is set to launch the product on Oct. 3 – six months after it was approved in the US.
Innovators are using increasingly complicated tactics in the high-stakes game of keeping biosimilars at bay to ensure their brand-name medicines can keep hauling in the cash for as long as possible.
A Massachusetts court's ruling invalidating a patent on Johnson & Johnson's Remicade (infliximab) appears to clear the way for Pfizer Inc. and Celltrion Inc. to finally launch their FDA-licensed biosimilar Inflectra (infliximab-dyyb). J&J, however, said it plans to appeal and any biosimilar launch would be considered "at risk."