Biosimilar Etanercept: Amgen’s Victory in Federal Appeals Court Further Delays Launch

On July 1, a US Appeals Court sided with Amgen, maker of Enbrel®, in patent litigation against biosimilar maker Sandoz. This is a source of continuing frustration for payers, health systems, and perhaps most of all, patients. Will this product be effectively shielded from competition for 31 years?

Sandoz’s Erelzi® was approved in 2016, but has not been available to the US market. Samsung Bioepis’ Eticovo® received approval from the FDA in 2019 and likewise is not yet launched. As reported previously, etanercept was first approved in the US in 1998, one of the first biologic response modifiers approved for autoimmune indications. Amgen believes that Enbrel should be protected from biosimilar competition until its final patents expire in 2029. Both etanercept biosimilar agents have launched in Europe, where in 2019, Samsung’s sales reached $486 million.

US sales of Enbrel in 2019 was approximately $5 billion, up from $4.8 billion in 2018. Enbrel generates Amgen’s greatest revenue today.  

In January 2017, Sandoz CEO Richard Francis thought that the legal battle would last no later than 2018. In 2017, that seemed a very long time. From 2020’s perspective, that was about $15 billion ago. Assuming an average of $5 billion per year in US sales, Amgen could rack up another $40 billion between 2021 and 2028 on Enbrel alone. The missed opportunity for savings is truly staggering (both in terms of lower biosimilar costs and avoided price increases).

In its press release on Amgen’s victory in the federal appeals court, Sandoz stated that it is evaluating all of its options, which may include an appeal to the US Supreme Court. Carol Lynch, President of Sandoz US, stated, “Our company respects valid intellectual property; however, Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”

Whether this case should be decided by the US Supreme Court is a separate question. This is an area where the Federal Trade Commission (FTC) might want to step forward and exert some authority. If this patent litigation is not anticompetitive in nature, I’m not sure what is. I’ve said it before: 31 years of marketing exclusivity flies in the face of reason.

Sandoz may be forced into the position of settling with Amgen (if Amgen wants to settle). Abbvie was well rewarded for its litigation efforts with adalimumab, resulting in licensing or royalty payments with eight biosimilar makers, and continued exclusivity through 2022. Ironically, Amgen was the first biosimilar maker to settle for an “early” adalimumab launch date in 2023.

This was not intended when the Obama administration signed the BPCIA into law, and Amgen knows well that every day it avoids competition is just icing on the revenue cake. Even if the suit was dismissed today by the Supreme Court, the marketing exclusivity period enjoyed by Amgen far surpassed the 12 years afforded by the BPCIA.

This may also be affecting company plans to offer additional etanercept biosimilars in the future. Although Coherus Biosciences still lists an investigational agent as completed phase 3 studies, it had finished them in 2017. There seems to be no rush in applying for FDA approval. Judging on the etanercept patent landscape for Sandoz, who can blame them?

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