Earlier this year at the 36th annual J.P. Morgan Healthcare Conference, Sanofi and Regeneron discussed the anticipated success of Kevzara (sarilumab), an interleukin 6 (IL-6) inhibitor approved in 2017 for moderate to severely active rheumatoid arthritis (RA) patients with an inadequate response or intolerance to at least one disease-modifying anti-rheumatic drug (DMARD). Kevzara is currently the second IL-6 inhibitor to gain approval for RA, eight years after the EMA’s approval of Genentech’s Actemra in 2009, which was followed by FDA approval in 2011.
Although Sanofi and Regeneron have high hopes for the performance of Kevzara, GlobalData anticipates the “me too” product of Actemra to face barriers to uptake given its price tag and the continued launch of biosimilars of anti-tumor necrosis factor (anti-TNFs).
Lines of Therapy
Current clinical practice advises the use of methotrexate as the first line of therapy for RA with the addition of conventional synthetic DMARDs (csDMARDs) until remission is reached. If remission or low disease activity cannot be reached by this approach, a biologic drug will likely be added, with anti-TNFs generally favored because of the extensive experience and comfort that rheumatologists have with their use.
First-generation anti-TNFs (Amgen’s Enbrel [etanercept], AbbVie’s Humira [adalimumab], and J&J’s Remicade [infliximab]) represent the first line of therapy for the biologic agents. The second and third lines of therapy continue to favor anti-TNF agents, followed by other biologics, including Actemra, Bristol-Myers Squibb’s Orencia (abatacept), and Biogen/Genentech’s Rituxan (rituximab), as well as small molecules, such as Pfizer’s Xelajnz (tofacitinib).
Positioning Kevzara as a First-Line Biologic a Challenge
Sanofi and Regeneron have positioned Kevzara for the TNF-failure patient population or ahead of the anti-TNF drugs following failure with a csDMARD. That being said, GlobalData expects Sanofi and Regeneron to have difficulty marketing Kevzara as a first-line biologic. Anti-TNF inhibitors have been entrenched as first-line biologics for the treatment of RA for 20 years following the approval of Enbrel in 1998.
Although Kevzara is priced at a discount to two of the three first-generation anti-TNFs, Humira and Enbrel, with an annual cost of therapy (ACOT) of $39,000 in the U.S. in comparison with approximately $53,000, the launch of biosimilars has offered a cost-effective alternative with a discount of 10 percent to 35 percent to their branded counterparts across the seven major pharmaceutical markets (7MM — the U.S., 5EU [France, Germany, Italy, Spain, and the U.K.], and Japan).
Kevzara Will Likely Fall Short of Blockbuster Status
In addition, the ACOT of Kevzara in the U.S. is substantially higher than that of Actemra, with an ACOT of approximately $24,000, marking a significant challenge for Sanofi and Regeneron’s me-too product. Despite these challenges, Kevzara, the first fully human monoclonal antibody (mAb) against IL-6, touts a stronger safety profile than Actemra, which is a recombinant human mAb and does not offer the same safety advantages of a fully human mAb. As such, GlobalData forecasts Kevzara to generate sales upward of $700 million across the 7MM by 2026, marking a significant opportunity for Sanofi and Regeneron, but not quite blockbuster status.
Senior Immunology Analyst