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First biosimilar to Remicade available in Canada
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Hospira announced it has made Inflectra, its biosimilar agent for Remicade, available in Canada, according to a company press release.
Inflectra is the first subsequent entry biologic to become available in Canada and is approved for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque psoriasis in combination with methotrexate. Products that are biosimilar to Remicade (infliximab, Janssen) have been available in Europe since 2006. Inflectra is currently available in 26 countries across Europe, according to the release.
The approval in Canada followed a phase 3 trial in patients with RA in which Inflectra met its primary endpoint of biosimilarity to infliximab.
“After a rigorous scientific review and approval process, the availability of this important product paves the way in Canada for patient access to lower-cost biologic therapies,” Sumant Ramachandra, MD, PhD, senior vice president and chief scientific officer at Hospira, said in the release.
“We are very proud to bring Inflectra to Canada - offering physicians, clinicians and patients a treatment option that maintains similar quality, efficacy and safety to its reference product,” Gerry Stefanatos, corporate vice president for Hospira in Canada and Australia/New Zealand, said in the release. “By providing subsequent entry biologic therapies, we can offer patients better access to high-quality, effective treatment options, and can help alleviate some of Canada's health care costs.”
According to the release, Hospira has also developed a patient-assistance program to provide services and assist with access to infusion clinics access to qualifying patients across Canada. In February, Hospira launched the product in Europe.
Reference: www.hospira.com.