-- Subsequent entry biologic (SEB) medicine provides a lower-cost, high-quality, safe and effective therapy for rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque psoriasis (Pso) --
Hospira, Inc. (NYSE: HSP), a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA™ (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. Approved by Health Canada, INFLECTRA is available to healthcare practitioners for the treatment of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque psoriasis.
An SEB (also referred to as a 'biosimilar' outside of Canada) is a biologic medicine made from a living organism or cell. SEBs deliver comparable clinical effects to their reference biologics while providing the opportunity for cost savings to the Canadian healthcare system.
"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 healthcare costs," said Gerry Stefanatos, corporate vice president, Canada and Australia/New Zealand, Hospira. "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."
In addition, Hospira has developed an in-depth patient assistance program to help provide infusion-clinic access to qualifying patients across Canada, along with numerous other patient services.
"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," continued Stefanatos.
INFLECTRA is biosimilar 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 CAD $800 million in Canada in 2014.
Hospira has the exclusive distribution rights to INFLECTRA in several major markets, including Canada. Bringing SEBs to Canada is the next major step towards driving healthcare cost savings and improving patient access to high-quality, more affordable biologic drugs. Biologic products, including SEBs, treat some of the most widespread and difficult-to-treat illnesses, such as cancer and chronic kidney diseases, as well as autoimmune diseases.
For an SEB to be approved in Canada, it must show comparative quality, clinical efficacy and safety to the reference product. SEBs developed in line with Health Canada's requirements can be considered a therapeutic alternative to an existing biologic. Health Canada approved INFLECTRA following a review of safety, efficacy and tolerability data from a comprehensive development program. In a phase 3 (randomized, double-blind) study in rheumatoid arthritis patients, INFLECTRA met its primary endpoint of biosimilarity to REMICADE. Safety and tolerability data showed a similar safety profile for INFLECTRA versus the known safety profile of REMICADE.
"Hospira is a leader in providing safe, effective, biosimilar medicines," said Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira. "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."
Patients and healthcare professionals outside North America have long had access to biosimilars -- the European Medicines Agency (EMA) approved the first biosimilar in 2006.
With one of the largest biosimilar pipelines in the industry, Hospira has many years of experience in the field of biologics. INFLECTRA is currently available in 26 countries across Europe, and during the last seven years, Hospira has provided more than 10 million doses of SEB medicines to patients in Europe and Australia.