Humira, developed by AbbVie, is a tumor necrosis factor alfa (TNFα)-inhibitor approved in the U.S. and Europe for the treatment of several chronic inflammatory conditions, including ankylosing spondylitis.
“Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan,” Heather Bresch, CEO of Mylan, said in a press release.
“Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab biosimilar in Europe is an exciting advancement for Mylan and for patients who are living with chronic autoimmune conditions and need access to a high-quality, more affordable treatment option,” she added.
With this decision, Biogen became the first company with the most approved biosimilars for the most prescribed anti-TNF biologic treatments in Europe, including Benepali, a biosimilar to Enbrel (etanercept), and Flixabi, a biosimilar referencing Remicade (infliximab). The two also received marketing authorization.
In November 2017, the European Commission also granted marketing authorization for Cyltezo, a Humira biosimilar developed by Boehringer Ingelheim. The decision followed the biosimilar’s approval by the U.S. Food and Drug Administration in August 2017.
The European Medicines Agency (EMA) in May 2017 accepted for review the marketing authorization application for Mylan/Fujifilm Kyowa Kirin’s biosimilar to Humira. A decision is expected later in 2018.
A biosimilar is a biological medicine with a high degree of similarity to another already approved biological medicine, called the reference medicine. In this case, Humira is the reference medicine.
Approval of biosimilars follows the same procedures and regulatory actions regarding pharmaceutical quality, safety, and efficacy that apply to all biological medicines.