In a major legal victory for Johnson & Johnson, the US District Court for the District of New Jersey has ruled in favor of the company and upheld three patents linked to its top-selling psoriasis drug, Stelara. The ruling came after a lawsuit was filed by Momenta Pharmaceuticals and Amgen, who had claimed that the patents were invalid and unenforceable.
Stelara is one of Johnson & Johnson’s most profitable drugs and generated $6.7 billion in sales in 2020. However, its market share and revenue could be reduced by the introduction of biosimilar competition. Biosimilars are less expensive alternatives to biological drugs such as Stelara.
The three patents upheld by the court relate to Stelara’s active ingredient, dosage, and method of use. The ruling means that Johnson & Johnson will retain exclusivity for Stelara in the United States until at least 2023, protecting it from biosimilar competition.
This legal victory follows another favorable ruling in a separate lawsuit against Samsung Bioepis, which is seeking to launch a biosimilar version of Stelara. Biosimilars have to overcome several regulatory hurdles before they can be approved, including proving their safety and effectiveness.
Despite the challenges that biosimilars face in getting approved, they have the potential to reduce healthcare costs significantly by providing less expensive alternatives to expensive biologic drugs. As more biosimilars gain approval and enter the market, the US biosimilars market is expected to grow rapidly in the coming years.
Amgen has announced its plan to appeal the ruling and remains committed to providing affordable biosimilars to patients. The company recently introduced a biosimilar version of AbbVie’s Humira, which is used to treat rheumatoid arthritis and other autoimmune diseases. In addition to Amgen’s appeal of the ruling, Samsung Bioepis is also likely to appeal the decision. Samsung Bioepis has been seeking to launch a biosimilar version of Stelara and is currently embroiled in a separate lawsuit with Johnson & Johnson over the drug’s patents.
The legal battles over Stelara’s patents underscore the growing importance of biosimilars in the pharmaceutical industry. While biosimilars offer savings to patients and healthcare systems, they also pose a threat to pharmaceutical companies that rely heavily on blockbuster drugs for a significant portion of their sales.
As more biosimilars gain approval and enter the market, the pharmaceutical industry will have to adapt to a changing landscape of competition and innovation. The legal battles over Stelara are just one example of the challenges and opportunities that lie ahead.
The court’s ruling in favor of Johnson & Johnson’s Stelara patents is a significant victory for the company, as it will continue to enjoy exclusivity in the US market. However, it also highlights the challenges posed by biosimilars to pharmaceutical companies and the opportunities they offer to patients and healthcare systems looking for less expensive alternatives to expensive biologic drugs.
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