Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods.
After losing its appeal, Sandoz Inc., the generics and biosimilars arm of Basel, Switzerland-based Novartis AG, said it’s evaluating its options, which may include an appeal to the U.S. Supreme Court. Absent a Supreme Court win or a licensing deal, Sandoz’s etanercept biosimilar, Erelzi, may not be able to launch in the U.S. until at least 2028.
As it is, Amgen’s U.S. patents, licensed from Roche Holding AG, have kept Erelzi off the U.S. market since 2016 when it gained FDA approval as the first U.S. biosimilar referencing Enbrel. Samsung Bioepis Co. Ltd.’s etanercept biosimilar, Eticovo, joined Erelzi on the bench after it was approved last year.
Meanwhile, Erelzi and other etanercept biosimilars have launched in Europe, where Pfizer Inc., of New York, had the licensing rights to Roche’s patents.
The difference is the tortuous route the U.S. etanercept patents traveled. The two patents Sandoz challenged – 8,063,182 and 8,163,522 – claimed priority to European Patent Application No. 90116707.2 and U.S. Application No. 07/580,013, both of which were filed in 1990. Roche subsequently abandoned the ’013 U.S. patent, but filed a continuation in 1993 that was subject to a restriction requirement by the U.S. Patent and Trademark Office (USPTO). Following a few more twists and turns, the USPTO finally issued the patents in 2011 and 2012, giving them expiration dates of 2028 and 2029, according to court documents.
By then, Enbrel had already reached blockbuster status in the U.S., having received FDA approval in 1998. In 2011, Amgen reported more than $3.7 billion in Enbrel sales, with Pfizer reporting similar sales in Europe. Last year, Enbrel generated more than $5.2 billion for Amgen, while Pfizer’s sales, impacted by European biosimilar competition, dropped to $1.7 billion, according to Cortellis.
Wednesday’s Federal Circuit decision is good news for Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN), which saw more than an 8% bump in its stock price. After closing at $235.86 Tuesday, Amgen hit a high of $256.23 July 1, closing the day at $255.12, up $19.26.
In responding to the news, Sandoz said it wasn’t so good for those who have to pay the tab of high drug prices. It cited estimates suggesting that a biosimilar etanercept could save the U.S. health care system around $1 billion annually.
Be that as it may, the appellate court’s decision was not unexpected, RBC Capital Markets LLC analyst Kennan MacKay said, as it affirmed last year’s lower court ruling. Looking ahead, “we see a low likelihood of Sandoz successfully overturning the court’s decision,” MacKay added.
As a result, RBC continues to model a slow decline (-6% year-over-year) in Amgen’s Enbrel sales to $3.2 billion in fiscal 2027 and then a a more substantial decline to $1.6 billion in 2030, MacKay said.