Amgen's new Enbrel patent could delay biosims for 17 years

Would-be Enbrel copycats, get out your handkerchiefs. Amgen ($AMGN) says it has a new patent protecting the blockbuster anti-inflammatory drug, which could protect it from generic rivals for another 17 years. If the patent holds up, then drugmakers with biosimilar ambitions--including Merck ($MRK), which has teamed up with South Korea's Hanwha Chemical to develop an Enbrel version--will find those aims squashed until 2028.

Enbrel had been expected to fall off patent in October of next year, although biosimilar versions weren't likely to immediately make their debut. Indeed, Amgen officials have said they don't expect to face Enbrel biosimilars for 5 years, partly because of use and formulation patents, as The New York Times points out. Those sorts of patents are more vulnerable to challenge than the basic one set to expire next year, however.

Still, waiting until 2016 or 2017 to launch an Enbrel copy is one thing, but waiting until 2028 is quite another. That alone puts a patent-challenge target on Amgen's newly minted IP. Whether Merck--or any other drugmaker working on a biosimilar form of Enbrel--would win that challenge is something for pharma-patent experts to debate. And no doubt they will.

- read Amgen's release
- get the NYT story

Suggested Articles

Saturday, AstraZeneca revealed more of the data that convinced the FDA to green-light Calquence in previously untreated chronic lymphocytic leukemia.

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.