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The mature rheumatoid arthritis ( RA ) market boasts ten different biologics representing several distinct drug classes, including blockbuster tumor necrosis factor alpha ( TNF -α) inhibitors Enbrel (Amgen), Humira (AbbVie), and Remicade (Janssen); four non- TNF -α biologics, including recently approved IL -6 inhibitor Kevzara; and oral Jak inhibitors Xeljanz (Pfizer) and recently approved Olumiant (Eli Lilly). The TNF -α inhibitors are the most widely prescribed biologics for RA patients refractory to conventional DMARD s, and the non- TNF -α biologics and Xeljanz largely compete for use in TNF -refractory patients. However, the premium-priced branded TNF -α inhibitors face a competitive threat from the launch of biosimilars, including biosimilar infliximab and biosimilar etanercept, which provide cost-effective ;With the impending entry of additional Jak inhibitors (AbbVie’s upadacitinib, Galapagos’s filgotinib), and biosimilars of several other TNF and non- TNF biologics, marketers are faced with fierce competition and increasing challenges to gain market uptake.
The TNF -α inhibitors—etanercept (Amgen/Pfizer/Takeda’s Enbrel, biosimilars), infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade, biosimilars), Humira (AbbVie/Eisai), Simponi/Simponi Aria (Janssen/Merck/Mitsubishi Tanabe), and Cimzia (UCB/Astellas)—are entrenched as first-line biologics in RA . What are key opinion leaders’ perceptions of the advantages and disadvantages of these drugs? What factors influence the prescription of one TNF -α inhibitor over another?
In patients with inadequate responses to TNF -α inhibitors, the competition among non- TNF -α inhibitors is fierce and expected to intensify with the entry of emerging therapies. What are key opinion leaders’ perceptions of the currently marketed non- TNF -α inhibitor biologics and novel oral kinase inhibitors, and where do these agents fit in their current treatment approach? Which emerging agents are likely to be most successful in targeting the TNF -refractory patient segment and gaining uptake in the RA market?
Additional oral Jak inhibitors (, Lilly/Incyte’s baricitinib, AbbVie’s upadacitinib, Galapagos’s filgotinib) are expected to launch during the forecast period. What will be the impact of the entry of additional novel oral therapies on the treatment algorithm for RA ? In which patient segments and lines of treatment will these oral therapies most likely be used? What is this drug class’s market potential in RA ?
Following the launch of biosimilar infliximab in Japan and Europe and biosimilar etanercept in Europe, biosimilar versions of adalimumab are also expected to enter the RA market during the first few years of the forecast period. Biosimilars of the non- TNF -α inhibitors abatacept, rituximab, and tocilizumab are also anticipated to launch during this time. How will the entry of biosimilars affect the market sales and patient share of currently marketed RA agents and the entry of emerging therapies?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 39 country-specific interviews with thought leaders.
Epidemiology: Number of total, diagnosed, and drug-treated prevalent cases of RA ; number of diagnosed prevalent cases of RA by severity.
Emerging therapies: Preregistered: 4 drugs; Phase III: 4 drugs; Phase II: 13 drugs; coverage of 2 select preclinical and Phase I products.