*

J&J seeks preliminary injunction over Samsung's sublicense

deal

with private label provider

*

J&J says said sublicense deal would hurt its market share

*

Samsung Bioepis launched its biosimilar in U.S. on Monday

(Adds details from lawsuit in paragraphs 5 and 12, attempt for

Samsung comment, paragraph 6, background throughout)

By Sneha S K and Patrick Wingrove

Feb 24 (Reuters) - Johnson & Johnson ( JNJ ) sued

Samsung Bioepis for allegedly breaching a contract agreement

over its launch of a biosimilar to Stelara, J&J's blockbuster

psoriasis treatment.

The lawsuit, filed late on Monday in a New Jersey federal

court, involves an unauthorized sublicense deal with a private

label provider that J&J declined to identify. The suit seeks a

preliminary injunction to bar U.S. sales of the private-label

version of Samsung Bioepis' Stelara biosimilar, called Pyzchiva.

Samsung and J&J signed a settlement agreement in July 2023

allowing for the launch of Pyzchiva this month.

Samsung Bioepis and partner Sandoz announced earlier

on Monday that Pyzchiva had been launched in the U.S.

J&J in the lawsuit claimed that the agreement did not permit

Samsung to introduce an additional private label drug at the

expense of J&J market share and fair competition. It also

requested a permanent injunction and financial damages as part

of its lawsuit.

Samsung Bioepis did not immediately respond to a request for

comment on the lawsuit.

Stelara, introduced in 2009, has been J&J's top-selling drug

since 2019, with sales reaching more than $10 billion in 2024.

Its patents began to expire in 2023, opening the door to

cheaper biosimilars entering the market. Legal agreements aimed

at escaping lengthy patent litigation delayed market entry of

Stelara biosimilars in the U.S.

J&J Chief Financial Officer Joe Wolk has said the Stelara

biosimilar market was likely to unfurl similarly to that of

AbbVie's ( ABBV ) blockbuster arthritis drug Humira - once the

world's best-selling prescription drug - given contracting

practices and doctor and patient resistance to switching

medicines.

AbbVie ( ABBV ) held onto almost all of the Humira market for more

than a year after close copies of the drug were launched in

early 2023. That changed when CVS Health removed Humira from its

list of covered drugs and more patients switched to a biosimilar

in three weeks than had in the prior 15 months.

CVS, which owns a pharmacy benefit manager that negotiates

rebates and fees with manufacturers and creates lists of

medications, known as formularies, that are covered by

insurance, replaced Humira with a biosimilar that was jointly

marketed with its Cordavis unit, a private label provider.

J&J in its lawsuit said Humira's market erosion was

illustrative of the harm Samsung Bioepis' private label deal

could have.

Stelara biosimilars launched in Europe, Canada and a few

other markets last year, and at least seven close copies of

Stelara are expected to begin selling in the U.S. this year.

Pyzchiva is approved to treat moderate to severe plaque

psoriasis, active psoriatic arthritis, moderately to severely

active Crohn's disease and moderately to severely active

ulcerative colitis.

Teva Pharmaceuticals and Alvotech ( ALVO ) last

Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food

and Drug Administration has allowed the use of Selarsdi as an

"interchangeable" Stelara substitute only after April 30, when

the exclusive rights for Amgen's ( AMGN ) version Wezlana

expire.