Amgen secures big win against biosimilars, Sandoz left feeling embarrassed

Amgen managed to dodge a big bullet for its top-selling product Enbrel, shaped in the form of Sandoz’s biosimilar Erelzi. Sandoz said it will appeal the decision but for now Erelzi will be kept of the market, embarrassingly for Sandoz this could delay the launch for at least a decade after receiving FDA approval in 2016 and executives praising the ‘soon to be roll out of the product’ stating that it could be rolled out as soon as next year.

This is a huge win for Amgen, as it will potentially save them multi-billions as Enbrel was approved back in 1998 and last year brought in sales of $4.8billion, which accounted for more than a fifth of the companies’ top line.

Sadly, this news is a recurring theme for the biosimilar industry in the US, with many biosim makers complaining that biologic drugs are often protected by ‘patent thickets’ which makes it incredibly hard for them to launch copycats. And once they reach the US market, they face further challenges in the form of companies like J&J developing strategies to combat against biosimilar competition such as striking “exclusionary contracts.”

This is not an issue faced in Europe where copycat biologics are faring much better, with AbbVie’s huge blockbuster facing a variety of biosimilar competition. The US markets response to the growing industry of biosimilars has come under fire many a time particularly by former FDA chief Scott Gottlieb who blasted drug makers for the ‘anemic’ market. The FDA has promised to act but many of the hurdles that biosim face fall outside of its jurisdiction. And with Gottlieb stepping down last year, it remains to be seen the priority that the FDA will place on this issue.

Amgen has managed to dodge the bullet for Enbrel but many of its other drugs including; Neulasta, Epogen and Sensipar have given ground to generics. Ironically, Amgen’s biosimilar division is set too boom with analysts from Cantor Fitzgerald forecasting $2.8billion in sales from Amgen biosimilars.

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