Just last year, New Jersey-based Johnson and Johnson filed a patent lawsuit against Amgen for producing its Stelara biosimilar aversion of the company’s best-selling drug, Stelara. According to a filing in the Delaware federal court, both firms have decided to put an end to the legal battle and settle.
In fact, in March, the drug giant faced backlash from a judge in New Jersey for failing to comply with court instructions after J&J brought a patent infringement case against Amgen in 2022.
The scolding from the judge, however, did not significantly hinder the litigation process, especially in light of the fact that both firms are moving towards putting the matter to rest.
According to a law that came out in 2009, companies are allowed to make biosimilar versions of complex biologic drugs that can act as substitutes, just as generic drugs can be used to replace conventional drugs.
Representatives from Johnson and Johnson have said that they will continue to “defend the intellectual property associated with our medicines to protect our ability to innovate and develop life-changing therapies for patients.”
While most terms of the settlement are being kept private, Amgen has announced that it has received a go-ahead to sell its biosimilar of Stelara by January 1st, 2025.
Despite the fact that Amgen filed an application with the FDA to approve its biosimilar in November last year, the firm is still waiting for approval. It is expected that a decision on the drug will be announced by the second or third quarter of 2023.
Before J&J’s Stelara, Amgen was also able to snatch AbbVie’s megablockbuster immunology drug, Humira’s exclusivity, as well, which marks a greater trend in the industry as major drugs start to face competition from biosimilar drugs.
Industry watchers predict that in the coming years, many other drugs will also lose exclusivity rights, and Stelara is just the first of many to come.
Amgen launched the Humira biosimilar Amjevita back in January after a patent settlement dating as far back as 2017 was signed between the two firms. This allowed Amgen to gain a half-year head start on other biosimilar players whose products are expected to hit markets in July this year, as announced by GoodRx.
Apart from the loss of exclusivity, copycat pressure is also weighing down the industry. Bristol Myers Squibb expects to face copycat pressure in the coming years for its blood thinner Eliquis and its big-selling cancer drug Opdivo, and it is already embroiled in facing a limited generic launch for its drug Revlimid.
Other drug makers expecting to face copycat pressure later in the decade include Merck’s Keytruda.
About Stelara biosimilar:
Stelara is a biological medication, meaning that it can never be exactly replicated since it is derived from living cells, and it is the biggest drug by sales for Johnson and Johnson, according to data from last year. The drug has been approved as a treatment for Crohn’s disease and other conditions like ulcerative colitis, plaque psoriasis, and psoriatic arthritis, and in this capacity, it has brought over $9.7 billion in sales.
