The biologics market in PsO has traditionally been smaller and less competitive when compared to rheumatology but the situation has changed over the last 2 years and is expected to change significantly in the near future.
The total European market for targeted immunomodulators continues to be led by Humira (adalimumab), AbbVie’s subcutaneous tumour necrosis factor (TNF) inhibitor and Janssen’s Stelara (ustekinumab), a human interleukin-12 and -23 antagonist. The latter has experienced strong uptake in both 1st and 2nd line patients and continues to remain ahead of other anti-TNFs and newer immunomodulating agents.
Among these newer agents are Novartis’ Cosentyx (secukinumab), an anti-IL-17 monoclonal antibody and Celgene’s Otezla (apremilast), an oral inhibitor of phosphodiesterase 4 (PDE4). While Cosentyx has predominantly been adopted as an alternative to established biologics in later lines of therapy, Otezla has seen uptake among biologic naïve patients representing an additional treatment step between older systemic therapies such as acitretin, cyclosporine and methotrexate and biologic agents.
Moreover, the recent introduction of biosimilar agents has increased the focus on cost of existing biologic therapies. Biologics are expensive, costing between £8,000 and £10,000 per patient per year. As a result, biosimilars have the opportunity to provide national healthcare services with significant cost savings and potentially allow for the wider use of biologics.
However, uptake of these agents has remained limited so far. The first set of biosimilars were based on Merck’s Remicade (infliximab), an intravenous anti-TNF which had historically been the least favoured anti-TNF among European dermatologists, who typically prefer subcutaneous agents. The subsequent launch of Benepali (etanercept), a biosimilar of Pfizer’s subcutaneous TNF-inhibitor Enbrel (etanercept) was expected to accelerate uptake of biosimilars and encourage substitution. However, even this product has done little to convince conservative dermatologists to jump on the biosimilar bandwagon.
Further biosimilar launches are expected in Europe with Sandoz’s Erelzi (etanercept) and maybe more importantly, Amgen’s Amgevita (adalimumab), the biosimilar equivalent of the market leading biologic, Humira approved by the EMA just last week. This may finally help to boost uptake of the class as formularies are updated and national healthcare systems reinforce guidelines to further encourage biosimilar use and substitution.
While biosimilars remain an uncertain threat, existing biologic agents still face competition from a number of novel biologics.
Following on from Cosentyx’ launch, Eli Lilly’s Taltz (ixekizumab) was approved by the EMA in April 2016 and became the 2nd IL-17-targeting drug to reach the market. However, despite a gradual European rollout, nearly a year on we have seen limited uptake of the drug by European dermatologists with reported 2016 revenue of $0.9m for the region. Taltz had hoped to differentiate itself due to its reduced frequency of administration when compared to Cosentyx but so far it seems to be struggling to gain a foothold in this increasingly competitive market. Taltz may find it even harder to differentiate itself with the impending approval of AstraZeneca and Leo Pharma’s Siliq (brodalumab), yet another anti-IL-17monoclonal antibody.
Within the non-TNF biologics class, IL-17 is not the only interleukin under consideration, with Janssen’s guselkumab, Sun Pharma/Almirall’s tildrakizumab and Boehringer Ingelheim/AbbVie’s risankizumab all inhibiting IL-23 and currently either awaiting approval or undergoing phase III trials.
However, the launch of new biologics and biosimilars means that dermatologists face a growing challenge in how best to use this abundance of new treatments.
The patient needs they are trying to address are wider than simply improving skin conditions. Current guidelines recommend several biologic treatments for moderate/severe PsO, alongside conventional systemic therapies and ultraviolet (UV) treatment, but there remains a need for greater clarity on how to manage biologic switching.
Moreover, despite the existence of some treatment guidelines and evidence of both the benefit and long-term safety of biologics, barriers remain limiting their access. From our own research, we know these barriers come from patients, physicians and external factors. Patients may be unaware of the benefits of systemic immunomodulators and have misconceptions of the risks involved, whilst physicians can lack knowledge of the guidelines or have a fear of legal liability. External factors such as poor healthcare infrastructure, low budgets, or lack of training are likely to also play their part.
So overall, the main battle for supremacy may come down to pricing, reimbursement/payer coverage and marketing and some players in the market may be better suited than others to address these factors.
The increasing number of biologics and biosimilars both in the market and in development provides the opportunity to deal with the cost barrier in accessing systemic therapy. The use of biosimilars has been shown to reduce healthcare costs and estimates have shown that the cost savings achieved by use of an etanercept biosimilar instead of Enbrel over 4 years could provide the opportunity to fund treatment for an additional 3,100 patients in the UK or 17,310 patients in Germany. This saving, combined with the argument that systemic penetration continues to be lower in PsO versus other autoimmune diseases, may allow for more growth in the market, which could be good news for some newer participants. However, it is likely that some will struggle to gain a significant foothold. Who the winners and losers will be remains to be seen, but it will be interesting to see how things play out in the European market in years to come.
Therapy Watch is a ‘real-time’ syndicated market tracking tool that provides strategic and tactical market information. It is run entirely online to ensure speed, quality and up-to-date access to the very latest market data. Launched in 2010, Therapy Watch PsO collects data from a panel of 200 dermatologists across 5 major EU markets (40 per country in France, Germany, Italy, Spain and the UK).
Living With offers comprehensive and cost effective insight into the patient journey from pre-diagnosis to stabilisation. These reports are based on quantitative market research studies conducted amongst large samples of patients living with specific chronic illnesses.
