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New EU and US approvals for Humira biosimilars

Samsung’s Imraldi and Boehringer Ingelheim’s Cyltezo receives nod from EMA and FDA, respectively

Humira

Samsung Bioepis has been granted approval from the EMA for its biosimilar of AbbVie's blockbuster inflammatory disease treatment Humira, while across the Atlantic Boehringer Ingelheim has picked up an FDA nod for its version.

Humira (adalimumab) has been the wold's biggest selling drug for years, and made $16bn in sales last year for AbbVie, with a little under $6bn of that total coming from markets outside the US. Biosimilars are typically cheaper - usually by around a third - than branded biologic drugs and because they are nearly identical to the original drugs they are very attractive to payers.

Samsung's new biosimilar - called Imraldi - has been approved in the EU for all 10 of the current Humira (adalimumab) indications, including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis.

It is the second Humira biosimilar to be approved in Europe after Amgen's Amgevita, which got the green light in March, and Samsung Bioepis' third approval in Europe for a TNF blocker after Benepali (etanercept) and Flixabi (infliximab). Samsung Bioepis and Amgen aren't expected to start marketing their biosimilars until after October 2018, when the primary patent protection for AbbVie's drug expires in the EU.

The CEO of the Korea-headquartered company Christopher Hansung Ko, said that the approval of its third anti-TNF drug in Europe is "testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost".

Meanwhile, Boehringer's biosimilar - called Cyltezo (adalimumab-adbm) and whose non-proprietary name follows FDA guidance requiring for an additional suffix identifier - has also been approved for the full range of Humira indications by the FDA. It is the second to claim marketing approval in the US market after Amgen's Amjevita (adalimumab-atto), which got the go-ahead in September 2016.

AbbVie is claiming patent protection for Humira in the US out to 2022 and has already taken legal action to try to keep both Amjevita and Cyltezo off the market. Thus far, Amgen has opted not to launch its biosimilar 'at-risk' but is waiting to see how the legal wrangling plays out.

Article by
Phil Taylor

29th August 2017

From: Regulatory

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