Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out?

Heads up, Novartis, Eli Lilly and Valeant: You’ve got company in the next-gen psoriasis space.

On Thursday, the FDA handed Johnson & Johnson an approval for Tremfya (guselkumab), a treatment for adults with moderate to severe plaque psoriasis. It's the fourth on the scene in a competitive field led by Novartis' Cosentyx, among that company's best-ever launches.

J&J’s newcomer will bear a $9,684 price tag, comparable to those of its biologic rivals, a company spokesman said via email. Assuming six maintenance doses of the drug per year, the annual cost will tally $58,100.

The New Jersey pharma said in a statement that it will “work closely with payers, providers and pharmacy benefit managers to ensure Tremfya is broadly accessible and affordable for patients,” adding that it offers a copay card for eligible patients that’ll sink out-of-pocket costs to $5 or less per dose.

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The green light came quickly for J&J, which cashed in a priority review voucher to get to market as quickly as possible. And now, Tremfya will join Cosentyx, Eli Lilly’s Taltz and Valeant’s Siliq in a market that’s recently exploded with new-age options. Analysts expect the J&J med to grab enough share to yield $1.56 billion in 2022 sales, according to EvaluatePharma's latest World Preview report.

Tremfya works differently from its peers: It selectively blocks interleukin-23, a cytokine involved in inflammatory and immune responses. All three of those rivals target interleukin-17, and as Credit Suisse analyst Vamil Divan wrote in a May note to clients, J&J is pitting Tremfya against Cosentyx in a head-to-head trial it hopes will prove the new med superior.

Even so, some industry watchers wonder “how the product might differentiate itself from competitors,” especially in such an “increasingly crowded” field, Divan said in the same note, adding that experts have previously told him “they did not feel there was a need for many newer agents.”

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For J&J, though, whatever sales Tremfya can generate will supplement those from older blockbusters threatened by new competition, including the next-gen psoriasis entrants. Stelara, which won its first go-ahead in psoriasis back in 2009, raked in $3.23 billion last year, but all three new IL-17 meds have thumped it in head-to-head trials.

And J&J superstar Remicade is up against some new challengers of its own; Pfizer launched a biosimilar, Inflectra, late last year, and in April, Samsung Bioepis won an FDA approval for its own knockoff, Renflexis. Samsung’s med will likely be along in October, and the launch could force discounts as the three companies jockey for formulary status.