6. Stelara

J&J's Stelara is the company's bestselling immunology product, generating more than $7 billion last year. (Johnson & Johnson)

Company: Johnson & Johnson 
2020 sales: $7.7 billion 
Key patent expirations: 2025 to 2026 

Many years after Johnson & Johnson’s high-profile Remicade biosimilar defense, the company will eventually have to face copycats for its new bestselling immunology drug, Stelara. 

Used to treat plaque psoriasis, psoriatic arthritis and Crohn’s disease, Stelara pulled in $7.7 billion last year, a 21% increase from 2019 despite the pandemic’s effects on the market. J&J still has some time to capitalize on the drug’s remaining patent life, but Moody’s analysts see potential copycats hitting the scene in the 2025-to-2026 timeframe. 

For its part, J&J said in its 2020 annual filing with the SEC that the last patent for the drug expires in 2023. Considering add-on exclusivity or biosim setbacks, many copycat biologics don’t always launch right when biologic patents expire. 

With billions at stake, numerous biosim makers are working on Stelara copycats. South Korea’s Celltrion seems to be the farthest along among the competition, with its candidate already in phase 3 testing against the branded biologic. That study should wrap up in the second half of 2022, so with success, the company could feasibly be ready to launch sometime in 2023 or 2024.  

RELATED: J&J's immunology meds Stelara, Tremfya posted big revenue gains, but pricing is slipping: analyst 

Several other biosim makers including Bio-Thera Solutions, Epirus Biopharmaceuticals and NeuClone are in early-stage testing with their potential copycats, according to the Generics and Biosimilar Initiative.  

As biosims march toward the FDA finish line, J&J will be looking to capitalize on Stelara and grow sales for other immunology meds. On the company’s fourth-quarter earnings call earlier this year, CFO Joe Wolk noted that the drug’s sales increases are coming from gastrointestinal indications, while another of J&J’s immunology offerings, Tremfya, is gaining steam in the psoriasis market. 

RELATED: With its Remicade biosimilar stymied by the brand, Pfizer sues Johnson & Johnson for 'anticompetitive' dealmaking 

Whenever Stelara biosims end up launching, market watchers can be sure that J&J will be ready. The company faced the first major U.S. biosimilar way back in November 2016 when Pfizer launched its Remicade copycat. Even though Pfizer offered a 15% discount, it struggled to gain traction because of the aggressive contracting J&J utilized to protect its blockbuster.

Pfizer ended up suing the Big Pharma rival in a closely watched lawsuit early in the U.S. biosimilar market evolution. J&J later sought to dismiss the lawsuit, but that effort failed. Last year, the court delayed some of the proceedings because of the pandemic.

6. Stelara