The Clock's Ticking on Stelara: Amgen, J&J Ink Patent Settlement

After Amgen filed its FDA application for a proposed biosimilar to Johnson & Johnson's Stelara, the latter company sued for patent infringement. (Al Seib/Los Angeles Times/Getty Images)

After the recent high-profile loss of exclusivity for AbbVie's megablockbuster immunology drug Humira, industry watchers' eyes moved to Johnson & Johnson's Stelara as one of the next major drugs expected to face biosimilar competition. Tuesday, the industry got more information about when exactly that clash might occur.

In J&J's patent case over Amgen's proposed biosimilar to J&J's Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar "no later than January 1st, 2025."

With that, the market exclusivity clock is ticking on J&J's biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications including plaque psoriasis, psoriatic arthritis and Crohn's disease.

Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the agency's decision should land sometime in the second or third quarter of 2023, according to J&J's lawsuit. 

J&J first sued Amgen for alleged patent infringement last year. In one wrinkle in this case, a judge scolded the New Jersey-based drug giant for its "failure to comply" with court instructions back in March. But that was just a blip on the radar in the litigation, and the sides have now moved to put the case to rest.

The Stelara loss of exclusivity is just one of many industry watchers expect in the coming years. Outside of this loss of exclusivity, Bristol Myers Squibb expects to face competition to its big-selling cancer drug Opdivo and its blood thinner Eliquis later this decade. BMS' Revlimid is already facing a limited generic launch, and that drug will face increasing copycat pressure in the coming years. 

Elsewhere, Merck's Keytruda is also slated to face copycat competition later in the decade.

For Amgen, this deal follows the company's high-profile launch of Humira biosimilar Amjevita back in January. Amgen inked the first patent settlement with Humira manufacturer AbbVie way back in 2017, allowing it to score a half-year head start on other biosimilar players. 

Several other Humira biosims are slated to hit the market on July 1, according to GoodRx.

Source: fiercepharma.com-Eric Sagonowsky

Editor: IPR Daily-Ann