Boehringer Ingelheim axes biosimilars development outside US

BI got its biosimilar of AbbVie’s inflammatory diseases drug Humira (adalimumab) approved by the FDA last summer, but is unable to launch because of the legal defences surrounding the originator drug in the US.

Humira’s global sales exceed $18 billion, generating revenues of $4.4 billion in Europe in the year ended in June according to figures from IQVIA.

However BI has its eyes on the $12.3 billion annual sales AbbVie is raking in from Humira in the US, where a thicket of patents has so far staved off any cheaper biosimilar competitors until 2023.

In Europe the patent expired last month, which will lead to a series of launches from a gang of companies with biosimilars approved and ready.

Even though BI has got its biosimilar, Cyltezo, approved by European regulators it has decided not to launch in Europe and to axe further development of biosimilars outside of the US.

With the other biosimilars approved, and AbbVie dropping the price of Humira to compete in a recently-signed deal with the NHS in England, competition is tough and BI has decided to focus on its legal tussle with AbbVie in the US over Humira.

In the US, Boehringer is aiming to succeed where other biosimilar manufacturers have failed and find a chink in the legal armour surrounding Humira, so it can get its cheaper competitor on the market ahead of 2023.

Novartis’ biosimilars and generics arm Sandoz became the latest biosimilars firm to concede defeat in the battle to overcome AbbVie’s patents, agreeing last month to defer a US launch of its Humira biosimilar Hyrimoz until September 2023.

Mylan, Samsung Bioepis and Amgen have also reached similar arrangements and will launch their competitors in July, June and January 2023, respectively.

A spokesperson for Boehringer Ingelheim said: "Boehringer Ingelheim believes the introduction of high-quality, lower-cost biosimilars is critical for both patients and the sustainability of the healthcare system.

"At this point in time, future biosimilars activities will be driven out of the US market, including partnership opportunities, while Boehringer Ingelheim is stopping development activities for the rest of the world. Our focus is on bringing Cyltezo (adalimumab-adbm) to the US market and we are committed to making it available to US patients as soon as possible and certainly before 2023."

The company said it "can’t comment on future plans" for Cyltezo in Europe, although an obvious solution would be to licence the biosimilar to another company.

BI’s German counterpart Merck KGaA has taken a similar approach, deciding to sell off its biosimilars pipeline to Fresenius Kabi last year.

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