Infliximab SEB launched in Canada

Biosimilars/News | Posted 10/04/2015 post-comment0 Post your comment

US-based generics major Hospira announced on 30 March 2015 the availability of its infliximab subsequent entry biologic (SEB) Inflectra in Canada, the country’s first SEB monoclonal antibody therapy.

Health Canada V13I20

Inflectra was approved by Canada’s drug regulator, Health Canada, in January 2014 for treatment of patients with ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis [1].

Inflectra is a SEB to the reference product Remicade (infliximab), and was the first of its kind to be approved through the Health Canada SEB regulatory pathway. Remicade recorded sales of nearly CA$800 million in Canada in 2014, according to IMS data.

Hospira gained European approval for the world’s first monoclonal antibody biosimilar infliximab (Inflectra/Remsima) as part of its collaboration with South Korean biologicals specialist Celltrion in September 2013 [2]. Although Inflectra and Remsima are approved in Europe for Crohn’s disease and ulcerative colitis, extrapolation to these indications in Canada was not recommended due to differences between Inflectra and Remsima and their respective reference products [3].

Hospira has developed an in-depth patient assistance programme to help provide infusion-clinic access to qualifying patients across Canada.

‘Canada is truly a unique country in that the majority of infliximab infusions take place outside of hospitals. Hospira has focused on providing the best possible experience for patients prescribed Inflectra, from the moment they leave the physician’s office to the actual administration of the product in the infusion clinics,’ said Mr Gerry Stefanatos, Hospira’s Corporate Vice President for Canada and Australia/New Zealand.

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1.   GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 10]. Available from: 
2.   GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 10]. Available from: 
3.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 10]. Available from:

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Source: Hospira

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