At EULAR this year there were 35 abstracts on subsequent entry biologics (SEBs). These include three for infliximab (CT-P13, SB2, BOW015) with CT-P13 approved in Canada (Inflectra), three for etanercept (SB4, GP205, CHS-0214) with SB4 approved in Europe, four for adalimumab (BCD057, SB5, M923, ADP 501,) and three for rituximab (GP13-201, BCD 020, CT-P1).
The findings are quite (bio)similar. What do I mean by that? From RCTs, switches from innovator to biosimilar after an open-label extension trial is completed and the awaited switch studies in the real-world, there were no signals (or more than expected) in terms of safety, efficacy/effectiveness, antibody production, etc. Nearly 700 patients from the DANBIO registry were switched to infliximab biosimilar with expected results where 6% stopped treatment due to loss of effect or adverse events (B Glintborg, #OP0225).
A reminder about biologics: they have significant benefit but biologics account for Canada's largest growth in pharmaceutical spending, with 9% growth last year compared to 6% in other pharmaceuticals. Biologics sales (all biologics for all indications) were $6.3B or a third of the entire Canadian market for pharmaceuticals in 2015, and included four of the top five selling drugs in Canada. The costs are non-sustainable. Market expansion has occurred annually for the 15 years since biologics were approved for rheumatology indications.
The biosimilars are here to stay. What does this mean to patients and payers? The choice of what to prescribe may be out of the hands of physicians and patients as would be the case in any therapeutic area where costly drugs are tiered and the lower priced drugs will likely be the reimbursed option on drug plans.
I think we have another large amount of data to relieve fears of small molecular changes resulting in clinically relevant differences. Perhaps embracing their benefits (cost savings to a system that is ever expanding) is the way to consider tiering the biosimilars. I think that strategies to obtain tight control in patients in the most effective and cost-effective manner are welcome and traditional DMARDs require optimal utilization prior to prescription of any highly expensive intervention. That seems to be the case in Canada and likely world-wide.
Dr. Janet Pope is Professor of Medicine at Western University and Division Head of Rheumatology. Dr. Pope's research interests include epidemiologic studies in scleroderma, classification criteria in systemic sclerosis, systemic lupus erythematosus and rheumatoid arthritis.View Full Bio