The originator infliximab, marketed across Europe by Johnson & Johnson as Remicade, is used to treat common autoimmune diseases, such as the bowel disorders Crohn’s disease and ulcerative colitis, as well as several types of arthritis. Biogen’s biosimilar infliximab – Flixabi – gained European Union (EU) approval in May 2016 for adults with Crohn’s diseases and ulcerative arthritis, as well as rheumatoid arthritis, ankylosing spondylitis, the skin condition psoriasis and its associated inflammatory condition psoriatic arthritis [1]. The drug has also been approved for use in children and adolescents (aged 6−17 years) with severe and active Crohn’s disease or ulcerative colitis.

Infliximab works by inhibiting tumour necrosis factor-alpha (TNF-α), a protein which regulates the immune response. By inhibiting this protein, the drug can treat diseases caused by an overactive immune system.

Flixabi’s approval was based on data from over a year-long phase III clinical trial. The trial followed the guidelines of the European Medicines Agency to compare the efficacy and safety of Flixabi and Remicade. The study was conducted in over 580 patients with moderate to severe rheumatoid arthritis.

The results showed that the drugs are very similar both in terms of safety and effectiveness. Over 65% of patients on Flixabi achieved a 20% improvement in tender or swollen joint counts, as well as a 20% improvement in three other criteria specified by the American College of Rheumatology. The figure for Remicade was very similar, at just over 69%. The drug was also well tolerated by patients, safe, and displayed similar activity in the body (pharmacokinetics) to Remicade.

The company announced its launch in the UK. This makes Biogen the first company to market two anti-TNF biosimilars in the country, the first being its version of Amgen’s TNF-α inhibitor Enbrel (named Benepali by Biogen). In a statement, the company said it was delighted to be the first drugmaker to bring two anti-TNF biosimilars to Europe.

Flixabi is the third low-cost alternative to Johnson & Johnson’s immunology blockbuster, following Pfizer’s Inflectra and Celltrion’s Remsima, and will represent a blow to the company’s profits. Remicade accounted for 9.4% of Johnson & Johnson’s revenues in 2013.

However, it should also generate savings for the healthcare system. Anti-TNF therapies cost the EU around Euros 10 billion annually – representing one of its largest pharmaceutical expenditures. Biosimilars can offer doctors and healthcare systems equally effective alternatives at much reduced cost. Biogen says Flixabi (alongside Benepali) will offer cost-effective alternatives for anti-TNF therapies and ‘drive meaningful savings’ across the EU. The company says the conditions these drugs can treat affect at least 600,000 people in the UK, and cost the National Health Service GBP 470 million each year.

Biogen’s collaboration with Samsung BioLogics which also has a further seven molecules under development. The company is looking to venture into the US anti-inflammatory market, and has submitted an infliximab biosimilar application to the US Food and Drug Administration [2]. It has also completed the regulatory process to enable a launch in South Korea [3].

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Biosimilars of infliximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis infliximab biosimilar accepted for review by FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-infliximab-biosimilar-accepted-for-review-by-FDA
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis adalimumab biosimilar submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-adalimumab-biosimilar-submitted-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis to launch infliximab biosimilar in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-to-launch-infliximab-biosimilar-in-South-Korea

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