-- 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) --
MONTREAL, March 30, 2015 /PRNewswire/ -- 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 2014.1
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.2
"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 2006.3
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.
About Hospira Canada
Located in Montréal, Quebec, Hospira Healthcare Corporation is the Canadian headquarters of Hospira and represents the company's second largest commercial presence. Hospira Healthcare Corporation markets products integral to increasing safety and reducing healthcare costs, including generic injectable drugs, infusion technologies and subsequent entry biologics (SEBs) or biosimilars -- which are biologic medicines that offer cost savings. Learn more at www.hospira.ca.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
INFLECTRA is indicated for use, in combination with methotrexate, for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. INFLECTRA is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies.
INFLECTRA is indicated for reduction of signs and symptoms, induction of major clinical response, and inhibition of the progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis.
Important Safety Information
INFLECTRA is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, INFLECTRA should be used after phototherapy has been shown to be ineffective or inappropriate. When assessing the severity of psoriasis, the physician should consider the extent of involvement, location of lesions, response to previous treatments, and impact of disease on the patient's quality of life.
INFLECTRA is contraindicated in patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections, in patients with moderate or severe (NYHA Class III/IV) congestive heart failure, and in patients with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving infliximab. Some of these infections have been fatal. Patients must be evaluated for the risk of tuberculosis, including latent tuberculosis, prior to initiation of INFLECTRA.
Hepatosplenic T-cell lymphoma has been observed for the reference product, infliximab, in disease populations for which INFLECTRA has not been authorized. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab.
The safety and efficacy of INFLECTRA has not been established in pediatric patients.
INFLECTRA should not be given to patients with a clinically important, active infection. Patients should be monitored for signs and symptoms of infection while on or after treatment with INFLECTRA™. New infections should be closely monitored. If a patient develops a serious infection, INFLECTRA therapy should be discontinued.
Lymphomas have been observed in patients treated with TNF-blocking agents, including infliximab. Patients with rheumatoid arthritis, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) for the development of lymphoma than the general population, even in the absence of TNF-blocking therapy. In the controlled portions of clinical trials of some TNF-blocking agents, including infliximab, more malignancies (excluding lymphoma and non-melanoma skin cancer [NMSC]) have been observed in patients receiving those TNF-blockers compared with control patients. In an exploratory clinical trial evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab treated patients compared with control patients. All patients had a history of heavy smoking.
The potential role of TNF-blocking therapy in the development of malignancies is not known. Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of the reference product REMICADE™. Chronic carriers of hepatitis B should be appropriately evaluated prior to the initiation of INFLECTRA therapy and monitored closely during treatment and for several months following discontinuation of therapy.
Infliximab has been associated with hypersensitivity reactions that vary in their time of onset. Most hypersensitivity reactions, which include urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hours of infliximab infusion.
Treatment with infliximab may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus- like syndrome following treatment with infliximab, treatment should be discontinued.
Use of live vaccines could result in clinical infections, including disseminated infections. It is recommended that live vaccines not be given concurrently with infliximab and that the vaccinations of patients be brought up to date with all vaccination guidelines prior to initiating INFLECTRA therapy.
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with infliximab.
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue to do so for at least 6 months after the last INFLECTRA treatment.
In studies with the reference product REMICADE, the most common adverse drug reactions reported from both clinical trials and post-marketing reports were infections, allergic reactions and infusion-related reactions. One of the most common reasons for discontinuing treatment in clinical trials was infusion-related reactions (dyspnea, flushing, headache and rash). Please consult the product monograph for full prescribing information.
Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements
This press release contains, or may contain, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira's biosimilars program and availability of Inflectra. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, except as required by law.
1 IMS CD&H data, 2014.
2 PLANETAS and PLANET RA 54 week trials.
3 European Commission. What you need to know about biosimilar medicinal products: Consensus Information Paper. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf. Accessed December 10, 2013.
SOURCE Hospira, Inc.