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Eye on Pharma: Janssen Sues Amgen, Express Scripts to Cover Adalimumab Biosimilar

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Janssen filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

Johnson & Johnson’s Janssen unit filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

Janssen Sues Amgen Over Ustekinumab Biosimilar

Janssen, a division of Johnson & Johnson (J&J), sued Amgen over its ustekinumab biosimilar referencing Stelara, claiming that Amgen’s intention to market the drug for rheumatic and gastrointestinal conditions infringes 2 of Janssen’s patents for the originator, according to a report from Reuters.

Stelara accumulated $9.1 billion in 2021, which represented about 18% of Janssen’s total annual revenue ($52 billion). Sales for the first 9 months of 2022 generated $7.3 billion for the company, up 7.9% from the same timeframe the previous year. Ustekinumab is used to treat Crohn disease, psoriasis, psoriatic arthritis, and ulcerative colitis.

J&J informed the court that Amgen’s filing indicates that the FDA will approve its biosimilar in the second for third quarter of 2023. Amgen is planning to launch the drug as early as next May.

The court filing could signal a pay-for-delay scheme in the ustekinumab space, a common move in the pharmaceutical industry, where a biosimilar manufacturer may pay to settle a patent infringement case in exchange for biosimilar launch postponement. This is the reasoning behind why adalimumab biosimilars are not allowed to enter the US market until 2023 despite being on the European and Canadian markets for several years.

Express Scripts to Cover Adalimumab Biosimilars

Following in the footsteps of OptumRx, Cigna’s pharmacy benefit manager (PBM) Express Scripts announced that it will add multiple adalimumab biosimilars to it formulary list at parity with the originator (Humira), according to Forbes.

Humira generates over $20 billion annually for drugmaker AbbVie, and come 2023, up to 10 adalimumab biosimilars will enter the US market: 1 in January followed by at least 7 in July. For years, stakeholders have wondered whether payers and PBMs were going to enact policies that would cover adalimumab biosimilars and how that coverage would compare with the originator.

“This decision helps us achieve lower costs for patients and plans while giving patients and providers choice and flexibility as additional biosimilars come to market…. Lack of competition allows sky-high prescription drug prices. We can generate more competition in the inflammatory drug class by adding biosimilars to our largest formularies in the coming months and…lower the costs of medications for the millions of people we serve,” said Harold Carter, chief pharma trade relations officer for Express Scripts.

Express Scripts did not disclose how many or which adalimumab biosimilars will be added to the formulary.

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