Patent loss for Humira® – Adalimumab products ready for take-off

Wed, 2018 / 10 / 17

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Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.

Prof. Matthias P. Schönermark, M.D., Ph.D.
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15 years after its approval in Europe, patent protection for the world’s best-selling immunosuppressant Humira® from the pharmaceutical group AbbVie expired in the night from the 16^th to the 17^th October 2018. Many international pharmaceutical companies are keeping a close eye on this major transition, as they will be allowed to launch their own biosimilars to the European market once the patent has expired.

According to the European Medicines Agency (EMA), five well-known manufacturers have already received approvals for Adalimumab products. Furthermore, physicians, pharmaceutical companies and health insurances have also been looking forward to the 17^th October 2018. The consequences are extensive: The pharmaceutical companies can expect an increase in sales and health insurers can expect cost reductions of up to 50% throughout the upcoming years. It remains to be seen which pharmaceutical company will make the most efficient use of the loss of AbbVie’s patent protection, and how AbbVie will try to maintain its current status as market leader.

In Germany, about 1.5 million people suffered from inflammatory rheumatic diseases in 2017. For the treatment of such diseases, as well as for chronical illnesses, Humira® is the top-selling immunosuppressant world-wide. Humira’s® monoclonal active substance Adalumumab can inhibit inflammatory reactions and reduce chronic inflammatory diseases. It is approved in 80 countries around the world and achieved a worldwide revenue of 15 billion dollars in 2017. In Germany, Humira’s® annual sales are estimated to about 1.02 billion euros. In comparison, health insurance companies pay about 2 billion Euro for generics, which saturate the German market to 80%.

The SKC Beratungsgesellschaft is one of the leading strategy consulting companies in the German healthcare sector. For more than a decade, we have been supporting pharmaceutical companies with strategic processes relating to existing and novel drugs based on our extensive knowledge of the healthcare sector and the industry.

BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Dr. Jörn Rösner

Sources (German only):
Ärzteblatt: Wettlauf um Rheumapatienten nach Patentablauf von Adalimumab
Deutsche Gesellschaft für Rhematologie: Pressemitteilung
GKV-Arzneimittel-Schnellinformation für Deutschland
Deutsche Apothekerzeitung: Humira-Patentablauf: Diese Biosimilars stehen in den Startlöchern
Apotheke Adhoc: Patentablauf Humira: Die Uhr tickt