• 01 Jun 2015

    Biosimilars in Rheumatoid Arthritis: What to Expect?

    Dinesh K. Kabaleeswaran, Analyst, Zitter Health Insights

    Rheumatoid arthritis (RA) has traditionally been one of the more competitive markets for new entrants with the TNF-alpha inhibitor class of drugs enjoying a good percentage of the market share. By effectively inhibiting the response to tumor necrosis factor (TNF), a cytokine released during the inflammatory response, Amgen’s Enbrel and Abbvie’s Humira have continued to be the undisputed market leaders. While Rituxan, Actemra, Xeljanz, Orencia rally together as alternatives to the TNF-alpha inhibitors, the agents contend with each other to treat patients resistant to the TNF-alpha inhibitors. However, with Humira’s patent set to expire in December 2016 and Amgen having completed a second successful Phase III study of its Humira biosimilar, the equilibrium is all set to alter and change the dynamics of the RA market.

    In a market where the patient population and the market value cap have been growing, the emergence of less expensive versions of “closely similar” Humira biologics will undoubtedly offset the domination of the TNF-alpha inhibitors. Research across multiple product lines at Zitter Health Insights, as a part of an integrated RA Market Update Report, has helped gain key insights into the most recent stakeholder trends in this space. In a survey of 302 patients conducted by Abandonment Insight Monitor, a quarter of Humira’s patients have indicated that they would be willing to switch to a biosimilar version of their medication when it becomes available even as two-thirds of Humira’s patients are uncertain about making the switch. While the patient’s influence needs to be factored, it is important to note that research undertaken by the Managed Care Biologics and Injectables Index (MCBII) team indicates that payers are significantly more likely to provide coverage if the agent is approved as highly similar with fingerprint-like similarity as opposed to highly similar. More specifically, 31% of payers stated that they would switch current Humira patients to its biosimilar if the agent is approved as highly similar. In contrast, nearly one-half of the payers responded that they would make the switch if the agent is approved as highly similar with fingerprint-like similarity.


    Patient and payer perspectives have always remained volatile and swung across multiple parameters. Payer coverage as a function of cost savings is an important barometer to monitor – analysis of data lead by MCBII reveals that almost one-third of the 102 payers surveyed expect the pricing of the biosimilar adalimumab to be at a 16-20% discount from the branded reference product. On the other hand, messages to payers collected by ongoing Zitter research have suggested not to expect deep discounts for the biosimilars. It is interesting to note that even as the discount debate rages in the payer and pharma world, patients have cited efficacy and safety as being the primary factors while making a potential switch to a biosimilar. In a survey of 236 patients hosted by AIM/CC, on a scale of 1-7, patients have ranked efficacy as the most important parameter, with a score of 6.4, and cost the fourth most important, with a score of 5.9.


    With patents set to expire in the coming years and biosimilars for Remicade and Rituxan in the pipeline, it is only natural that manufacturers of the branded agents face the “patent cliff” phenomenon, the degree of which will be shaped by the emergence of the biosimilars. Zitter Health Insights will continue to deliver key insights and the most recent trends from this space. Meanwhile, we invite you to share your thoughts and perspectives on this increasingly competitive category.