Teva CEO says not too late to launch Humira biosimilar in 2024

By Steven Scheer

JERUSALEM (Reuters) -Teva Pharmaceutical Industries will still pursue launching a biosimilar of AbbVie’s blockbuster arthritis drug Humira next year despite a crowded marketplace, Chief Executive Richard Francis said on Wednesday.

Francis said Teva’s Iceland production site still needs to pass an inspection before it gets U.S. Food and Drug Administration approval, likely in the first half of 2024.

Eight companies have launched Humira biosimilars in the United States this year.

“Will the opportunity be lost by next year? I don’t know. I doubt it. It’ll be less than if we launched this year. But I still see it as an opportunity,” Francis told Reuters after Teva issued second-quarter results.

“It’s always going to be a challenging market but I do see it’s worth the effort for 2024.”

Francis, who took over the Teva helm at the start of 2023, noted that the U.S. biosimilars market is still evolving.

“There’s always room for everybody. It just depends what you want to do on price,” he said, adding that Teva’s advantage would be an autoinjector that makes it easier when trying to move patients from one therapy to a new one.

“You’ve got to have everything to be as good, if not better, than the originator. I think we have that,” he said.

Francis said the quality of Teva’s biosimilar would make it attractive to pharmacy benefit managers (PBMs), the middlemen that negotiate drug prices and recommend coverage for most insured Americans.

Two of the largest PBMs – Cigna Group’s Express Scripts and UnitedHealth Group’s Optum RX – only chose to cover three Humira biosimilars from Amgen, Boehringer Ingelheim and Novartis’ Sandoz unit for 2023 alongside the branded drug.

AbbVie has offered discounts to shield itself from market share erosion for what had once been the world’s top selling prescription drug, but Francis said prices of alternative versions typically end up lower than the originals.

“If they dramatically reduce (prices) that’s going to put them under significant pressure on their P&L. So there’s only so far they will go,” Francis said. “They’ve modeled that and they’ve worked out what attrition is going to happen when, and what price they can give up when. And we’ve seen that across a number of biosimilars.”

Out of the eight drugmakers that launched Humira biosimilars in the U.S. this year, three kept their list price within 5%-7% of AbbVie’s, two priced at an 85% discount and three offered both types of prices.

Unlike easy to produce generic versions of pills, complex biotech drugs made from living cells cannot be exactly duplicated, leading to the term biosimilars.

Teva has 16 biosimilars in its pipeline, including a version of Johnson & Johnson’s blockbuster psoriasis treatment Stelara. That will be launched in the U.S. in 2025 under a deal between the two companies.

“No one of them was ever going to be our biosimilar strategy,” Francis said.

“We’ll have Humira, it will be maybe not as big as we’d initially forecast. But we will have Stelara and then we’ll have a number of other products that are coming from in house as well as from other partners.”

(Reporting by Steven Scheer; Additional reporting by Patrick Wingrove in New York; Editing by Caroline Humer and Bill Berkrot)

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