Shifts in the U.S. Rheumatoid Arthritis Market Access Landscape Due to Oral Kinase Inhibitors, New Biologics, and Biosimilars: Insights from Payers and Physicians | Physician & Payer Forum | US | 2014

The entrenched positioning of biologics (in particular, tumor necrosis factor-alpha [TNF-alpha] inhibitors) to treat moderate to severe rheumatoid arthritis (RA) has generated a multibillion-dollar market. Bristol-Myers Squibb’s selective costimulation modulator Orencia (abatacept), Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s B-cell inhibitor Rituxan (rituximab), and Roche/Chugai’s interleukin-6 (IL-6) inhibitor Actemra (tocilizumab) largely compete for TNF-refractory patients. Since the launch of an SC formulation of Orencia in 2011, several biologics (Orencia, Janssen/Merck/Mitsubishi Tanabe’s Simponi, and Actemra) have become available in both IV and the SC formulations. In November 2012, Pfizer/Takeda’s oral janus-activated kinase (Jak) inhibitor, Xeljanz (tofacitinib), was approved. Xeljanz’s convenience (twice-daily oral administration) and efficacy profile, which is similar on several key outcome criteria to that of biologics, make it a compelling option for RA patients, although it does possess a black-box warning, as do many biologics, for its risk of serious infection and malignancy. An additional Jak inhibitor, Eli Lilly/Incyte’s baricitinib, and additional biologics (Novartis’s IL-17 inhibitor secukinumab, Sanofi/Regeneron’s IL-6 inhibitor sarilumab, and Janssen/GlaxoSmithKline’s IL-6 inhibitor sirukumab) have the potential to launch over the next few years. Biosimilar versions of AbbVie/Eisai’s Humira (adalimumab) and Rituxan are expected to launch in 2017. Thus, competition in this market will become increasingly fierce.