Sandoz Still Trying To Sneak Past Amgen’s Stealth Enbrel Patents
This article was originally published in The Pink Sheet Daily
Sandoz appeals dismissal of suit seeking a ruling that its Enbrel biosimilar candidate does not infringe patents Amgen licensed from Roche; judge says complaint is premature until an application is filed.
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Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.
Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.
Amgen’s patent may keep Enbrel biosimilars off the market until at least 2028. Other biosimilar sponsors could face similar submarine patents that derail their commercialization plans.