Boehringer wins EU approval for Humira biosimilar
- Boehringer Ingelheim' GmBH's Cyltezo, a biosimilar form of AbbVie Inc.'s Humira, has secured approval in Europe for the treatment of chronic inflammatory disease, following a recommendation for approval in September.
- The route to market isn't clear, though. Boehringer Ingelheim won't launch Cyltezo in Europe until the expiration of the supplementary protection certificate for adalimumab, the active ingredient in Humira, which should occur in October 2018.
- Cyltezo also picked up U.S. approval in August, when it became the second biosimilar to Humira to gain a Food and Drug Administration thumbs up. However, as Boehringer Ingelheim is currently in litigation with AbbVie, the drug is not yet available in the U.S. either.
Europe is well ahead of the U.S. for biosimilar approvals. While the FDA has so far given the go-ahead to seven copycat biologics, there are currently 36 that have received a central marketing authorization from the European Medicines Agency.
"Cyltezo is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases," said Ivan Blanarik, head of biosimilars at Boehringer, in a Monday statement.
Boehringer says it won't launch Cyltezo in Europe before 2018. The situation is a little more tense in the U.S., where a litigation battle is under way with originator AbbVie.
Amgen Inc. has reached the other side of its own battle with AbbVie over the Humira biosimilar Amjevita (adalimumab-atto). Like Boehringer Ingelheim, Amgen will be launching in Europe under the brand name Amgevita in October 2018, which will mean competition from essentially day one between the two companies. However, Amgen has to wait until 2023 to hit the U.S. market. It remains to be seen whether the same will be true for Boehringer Ingelheim, but a lengthy hold-off is surely within the realm of possibility.
Boehringer Ingelheim is also developing BI 695502, a biosimilar form of Roche's Avastin (bevacizumab) that is in Phase 3 testing, and has other candidates in preclinical development.
- Boehringer Ingelheim GmBH Press release
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