New biosimilars approved in the United States and Europe are expected to cut into the profitability of the blockbuster drug adalimumab (Humira, AbbVie) for Crohn’s disease and other autoimmune conditions.
FDA approved Boehringer Ingelheim’s adalimumab-adbm (Cyltezo) on 25 August. The drug, delivered by subcutaneous injection, treats moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, moderate to severe chronic plaque psoriasis in adults, along with other conditions.
Plus, Samsung Bioepis said last week that the European Commission approved Imraldi, a biosimilar to Humira.
However, before the launch of Cyltezo and Imraldi, Humira’s sales were not suffering, despite another biosimilar to Humira (adalimumab-atto, Amjevita from Amgen) gaining FDA approval in late September, 2016.
"The introduction of biosimilars into the autoimmune therapeutic class is looking to be one of the big disrupters for pharmaceutical industry in 2017 and beyond," says Robert T. Taketomo, PharmD, MBA, president/CEO, Ventegra, Inc., a California Benefit Corporation. "How payers, patients, providers and the pharmaceutical industry respond to these agents will establish a blueprint for how the market for biosimilars will impact pricing, discounts, medical policies, benefit designs and formularies.”
Sales of Humira soared 15.1% on a reported basis during AbbVie’s first fiscal first quarter of 2017. And sales of the drug reached $16.1 billion in 2016, according to Seeking Alpha.
Meanwhile, Samsung Bioepsis said it is the first drugmaker to obtain European approval for a third TNF inhibitor.
“This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.
The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway.