Amgen has been in a yearslong legal battle with the Novartis generic unit, Sandoz, as Sandoz has been trying to bring its biosimilar version of Enbrel to the market.
Enbrel is an inflammatory disease drug approved to treat rheumatoid arthritis, psoriatic arthritis and plaque psoriasis. Sandoz developed a biosimilar version of Enbrel called Erelzi, which won FDA approval in 2016, Biopharma Dive reported.
With Amgen’s patents affirmed, the drugmaker may not face biosimilar competition for Enbrel until 2029, more than three decades after the drug was approved in 1998.
Enbrel is Amgen’s largest moneymaker, bringing in more than $5.2 billion in 2019, according to Biopharma Dive. The drug has accounted for about a quarter of Amgen’s sales for the last three years.
In a written statement, Sandoz said it is evaluating next steps, including possibly taking the case to the Supreme Court.
“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,” said Carol Lynch, present of Sandoz’s U.S. division.
Read the full article here.
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