Enbrel Company: Amgen 2019 sales: $7.2 billion Projected 2026 sales: $4.02 billion Projected CAGR: -8% Used for: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis
Amgen had a major cloud over its head with blockbuster stalwart Enbrel because of a patent dispute with Novartis over a biosimilar version of the drug. A recent ruling in favor of Amgen could take that cap off Enbrel's future chances and spell hope for long-term sales.
Enbrel brought in $7.2 billion in sales in 2019, well on top of as Amgen's bestselling drug. Due perhaps to the uncertainty around Novartis' biosim, Evaluate Pharma put Enbrel's sales forecast at just $4.02 billion in 2026.
However, that forecast predates the patent ruling, and with biosimilars now likely off the table until 2029, it could be an undershot—provided Enbrel can continue to innovate in finding patients.
RELATED: Amgen's Enbrel fends off biosimilar threat—and heads toward blockbuster superstardom In early July, a U.S. Federal Appeals Court upheld a 2019 ruling from the New Jersey District Court that has kept Novartis’ biosimilar rival to Enbrel off the market.
Novartis' biosimilar, Erelzi, nabbed an FDA approval way back in 2016, but its U.S. launch had been delayed by the ongoing patent dispute. The FDA approved a second biosimilar version of Enbrel in 2019, Eticovo from Samsung Bioepis, but Amgen immediately challenged it with a suit similar to the one it filed against Sandoz.
The successful ruling in Sandoz' case will likely keep any Enbrel copycat off U.S. shelves until 2029.
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Meanwhile, Amgen continues to find new ways to preserve Enbrel’s market share despite more than 20 years on the market.
In December, the drugmaker signed a
deal with pharmacy benefits manager Abarca in which Amgen agreed it would pay a rebate for any patient that stops using the drug after three months.
That was the second outcomes-based deal Amgen formed for Enbrel, which is approved to treat rheumatoid arthritis and five other inflammatory conditions. In 2017, Amgen agreed to a
pact with Harvard Pilgrim Healthcare that stipulated it would reimburse less for the drug if patients scored below certain thresholds on compliance, as well as other factors such as the need to take additional drugs to control their pain.
And the company may join its immunology peers and test Enbrel against COVID-19, given the inflammatory response that drives so many severe cases of coronavirus-related illness. Enbrel's fellow Amgen med Otezla, a PDE4 blocker, is under study for its potential to prevent respiratory distress in patients with the virus. But the class of medicines that Enbrel belongs to, TNF inhibitors, is one “that we’re considering, as well, in this regard,” CEO Robert Bradway recently