Humira® (adalimumab) is a TNF-inhibiting, anti-inflammatory monoclonal antibody – the first fully human mAB approved by the US FDA – that binds to tumor necrosis factor-alpha (TNFa), preventing it from binding to TNFa) receptors and thus from causing the inflammatory responses associated with autoimmune diseases. It is approved or been shown to be effective for the treatment of a number of these diseases, including rheumatoid and psoriatic arthritis, ankylosing spondylitis, Chrohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and juvenile idiopathic arthritis.
Humira® was originally manufactured and marketed by Abbott Laboratories after its acquisition of BASF Pharma and is currently owned by Abbvie, a company split off from Abbott. Biosimilar adalimumab products from Samsung Bioepsis and Biogen (Imraldi) and Amgen (Amgevita) will be launched in October 2018 in Europe. Boehringer Ingelheim is also expected to launch its adalimumab biosimilar, Cyltezo in Europe within the next year. Mylan will be commercializing Fujifilm’s adalimumab biosimilar in the European market once approval from EMA – expected in the first half of 2018 – is received. Abbvie has managed, however, to delay the introduction of these Humira biosimilars in the US until 2023.
In Europe, uptake of Humira biosimilars including Imraldi is predicted by GlobalData to be fairly high. A combination of lower (10-20%) pricing for the biosimilars compared to Humira and quotas established by regulatory agencies will have a significant impact.
In England, for instance, the National Health Service (NHS) recommends that within 12 months of the launch of a biosimilar, 90% of new patients and 80% of patients currently receiving therapy should be prescribed the biosimilar rather than the branded drug product. Other European countries have similar quotas.
GlobalData expects actual uptake to be lower than the quotas, but still reasonably high. "Actual uptake does vary among different hospitals and healthcare facilities and could, in fact, be lower. On average, gastroenterologists treating ulcerative colitis, anticipate prescribing the biosimilar versions to around 45% of the total adalimumab-treated population in the EU by 2021,” said GlobalData Associate Director of Immunology Dr. Lakshmi Dharmaraja. The company also believes that the uptake of Humira biosimilars will be slower than that for Remicade ® (infliximab) biosimilars for gastroenterology indications because hospitals play more of a role in decision making for patients treated with the latter drug, while those treated with Humira tend to be managed by their individual physicians in an outpatient setting.
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.