LONDON, Aug 25 (APM) - Samsung Bioepis/Biogen's biosimilar of AbbVie's Humira (adalimumab) has been approved in Europe, representing a potentially serious blow to the world's biggest-selling drug, it has been announced.
Imraldi is approved for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis, Biogen said in a late Thursday statement.
The biosimilar has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen.
Imraldi is the third anti-TNF biosimilar from Biogen to be approved in Europe, following authorisation in 2016 of Benepali (etanercept), a biosimilar of Pfizer's Enbrel (etanercept) and Flixabi (infliximab), a biosimilar of Merck & Co/Johnson & Johnson's Remicade.
Biogen said anti-TNF therapies represent some of the biggest drug expenditure in Europe, costing an estimated 8 billion euros annually from 2011 to 2014.
Introducing biosimilars of the top three anti-TNF therapies in Europe could lead to estimated potential savings of up to 9.7 billion euros between the patent expiry date of each reference product and 2020, it added.
With the approval of Imraldi, Biogen said it has become the first company to have approved biosimilars for all three of these therapies.
Jean-Paul Kress, EVP International and Head of Global Therapeutic Operations, Biogen, said: "Today's decision marks another positive step in transforming the lives of people with chronic autoimmune conditions. As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics."
Blow for AbbVie
Approval of Imraldi represents a serious threat to sales of Humira, the world's biggest-selling drug. Last month, AbbVie announced that sales of Humira in the second-quarter rose 18% to $3.2 billion. (APMMA 54117)Patents in Europe on the drug are set to expire in late 2018 (APMMA 51559) (APMMA 51559), though this occurs later in the U.S.
In addition to Imraldi, other would-be competition includes Boehringer Ingelheim, which has won favourable U.S. patent court decisions in a legal battle following its early launch of the drug (APMMA 53880). Sandoz has also filed for biosimilar approval in Europe (APMMA 53977).
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