Findings presented at EULAR this week from the first real-world study in patients with rheumatic diseases supports switching from J&J’s Remicade to Hospira’s biosimilar Inflectra.
The annual meeting of the European League Against Rheumatism is taking place in Rome until 13 June, and US biosimilar-maker Hospira along with its biopharma partner Celltrion are keen to highlight these new results.
Biosimilars are not as easy to make as generic drugs as they usually require a certain amount of limited clinical trial data and are typically biologics – meaning their development and production are more complicated and costly.
But it can be a lucrative area for drugmakers even though there is greater upfront cost than with a generic, especially in emerging markets.
This latest data comparison looked at the outcomes in 39 patients after a mean of four years of treatment with Remicade, with the outcomes of those same patients after a median of 11 months following a switch to Inflectra (infliximab).
Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.
“This post-market study shows that patients with various rheumatic conditions who are stable on Remicade treatment don’t experience a loss of effectiveness or unexpected side effects when switched to biosimilar infliximab,” says Dr Tuulikki Sokka, head of Rheumatology at Jyväskylä Central Hospital, Finland, and author of the study.
“Real-world studies such as this can help provide additional confidence in biosimilars, giving clinicians an opportunity to reduce healthcare spending and provide greater access to biologic medicines for patients in need.”
Hospira was the first firm to meet the European Commission’s approval for a biosimilar monoclonal antibody therapy with Inflectra in 2013, when it also recorded European sales of almost €2 billion.
It is now available in 26 European countries and launching in 13 new markets earlier this year – following the patent expiry of J&J’s pharma unit Janssen’s Remicade.
It has been approved for the treatment of RA, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
It’s not all bad news for Janssen however despite patency woes, as it too will be presenting 17 immunology abstracts in ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and psoriasis at EULAR this week.
Newman Yeilding, its head of immunology development within R&D says: “Our commitment to immunology and the continued research and development of innovative solutions for the treatment of complex immune and inflammatory diseases has never been stronger. We are pleased to present data from our immunology portfolio at the EULAR congress.”
In fact UK watchdog NICE has just performed a U-turn on the firm’s Stelara (ustekinumab) and has now recommended the drug for the treatment of psoriatic arthritis.
Stelara was rejected by NICE last year after the body concluded that it ‘appeared less effective’ than TNF alpha inhibitors, and was not cost-effective.