- The new independent clinical study data presented at EULAR's annual congress this week adds to the growing wealth of data for Hospira's Inflectra (infliximab), the first biosimilar monoclonal antibody, which received approval from the European Commission in 2013
- Inflectra provides a potentially cost effective treatment option for people suffering from severe diseases such as rheumatoid arthritis (RA) and ankylosing spondylitis (AS), while maintaining comparable quality, efficacy and safety to the reference infliximab
- The large savings expected to be generated with biosimilars provide an opportunity to improve patient access to life-changing medicines
- Additional abstract reveals data showing no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade
ROME, June 10, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), a global leader in biosimilars, today announced the results of an independent clinical study, showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Remicade™ to Inflectra. The study entitled, "Clinical experience with infliximab biosimilar – switch from Remicade. Abstract SAT0174," supports the use of Inflectra, the first biosimilar monoclonal antibody approved in the EU, as a treatment option for people suffering from inflammatory conditions such as rheumatoid arthritis, who are currently receiving stable treatment with reference infliximab.1
The data, presented at the European League Against Rheumatism Annual Congress (EULAR 2015), compared outcomes in 39 patients after a mean of four years of treatment with Remicade, with the outcomes of those same patients after a median of 11 months following a switch to Inflectra.1 Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.1 Full details of the study can be found at: https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252112
"This post-market study shows that patients with various rheumatic conditions who are stable on Remicade treatment don't experience a loss of effectiveness or unexpected side effects when switched to biosimilar infliximab," said Dr. Tuulikki Sokka, Head of Rheumatology at Jyväskylä Central Hospital, Finland, and author of the study. "Real world studies such as this can help provide additional confidence in biosimilars, giving clinicians an opportunity to reduce healthcare spending and provide greater access to biologic medicines for patients in need."
In addition, the results of a meta-analysis of 14 randomised controlled trials assessing safety incidences in 1,454 patients were announced at EULAR. The abstract is titled, "Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433." This analysis compared the safety profile of Inflectra from clinical trials in RA and AS, with historical safety data from Remicade clinical trials. The results revealed no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade.2
"The study presented at EULAR today provides assurance that switching to Inflectra is a viable, effective treatment alternative to maintenance with Remicade," said Paul Audhya, M.D., Vice President, Medical Affairs, Europe, Middle East and Africa, Hospira.
It has been estimated that 40 percent of RA patients in Europe have severely restricted access to biologics due to the high cost of treatment, with large variations in patient access levels seen across Europe.3 The potential cost savings from biosimilars for healthcare systems could improve patient access to these life-changing medications. A recent study looked at the estimated savings expected from switching RA patients from Remicade to biosimilar infliximab in six countries in Central and Eastern Europe. The study showed that 1,200-1,800 additional RA patients could be treated over a three-year period if the savings of between €15.3-20.8M were spent on reimbursement of additional biosimilar infliximab treatment.4
"With more and more people living with chronic diseases, such as RA, the strain on our healthcare economy is only going to increase. Hospira is committed to delivering high quality, biosimilar medicines at a lower cost than the reference product, to increase patient access to biologic medicines," said Paul Greenland, Vice President Biologics, Hospira.
Inflectra received its authorization from the European Commission (EC) in September 2013 for all the licensed indications of Remicade, which has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013.5 Inflectra is now available in 26 European countries, launching in 13 new markets earlier this year, following the patent expiry of Remicade. Inflectra is also available in Canada, has recently been approved by the regulatory authority, ANVISA, in Brazil, and has been submitted to the U.S. Food and Drug Administration (FDA) for approval.
With one of the largest biosimilar pipelines in the industry, Hospira has more than seven years' market experience in biosimilars in the EU. The company has several biosimilars on the European market, including Inflectra (infliximab), Retacrit™ (epoetin zeta) and Nivestim™ (filgrastim). Hospira has delivered more than 10 million doses of biosimilar medicines to patients worldwide.6
Biosimilar medicines are biologics with comparable quality, safety and efficacy as their reference biologics, but are provided at a lower cost. Biosimilars undergo an extensive comparability exercise with the reference product and, based on the totality of evidence submitted to the regulatory body, the biosimilar may be approved for all the licensed indications of the reference biologic, and launched after patent expiry of the reference product.7
Inflectra (infliximab) is a chimeric human‑murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF alpha but not to lymphotoxin alpha (TNF beta). Inflectra is indicated for:
Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
- adult patients with active disease when the response to disease‑modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
- adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X‑ray, has been demonstrated.
Adult Crohn's disease
Inflectra is indicated for:
- treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
- treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Paediatric Crohn's disease
Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6‑MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Inflectra should be administered
- in combination with methotrexate
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Important Safety Information
There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia, in patients taking Inflectra. Some of these infections have been fatal. Patients should tell their doctors if they have had recent or past exposure to people with TB. Their doctors will evaluate them for TB and may perform tests for TB. If patients have latent (inactive) TB, their doctors should begin TB treatment before they start Inflectra. Inflectra can lower patients' ability to fight infections, so if they are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu-like symptoms or warm, red or painful skin while taking Inflectra, patients should tell their doctors right away. Also, patients should tell their doctors if they are scheduled to receive a vaccine or if they have lived in a region where histoplasmosis, blastomycosis or coccidioidomycosis are common.
Reports of a type of blood cancer called lymphoma in patients on Inflectra or other TNF blockers are rare, but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Rarely, children and young adults who have been treated for Crohn's disease or ulcerative colitis with Inflectra in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTCL) that often results in death. Patients taking Inflectra or other TNF blockers may be at an increased risk for developing lymphoma or other cancers. Patients should also tell their doctors if they have had or develop lymphoma or other cancers or if they have a lung disease called chronic obstructive pulmonary disease (COPD).
Many people with heart failure should not take Inflectra; so prior to treatment they should discuss any heart condition with their doctors. Patients should tell their doctors right away if they develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of ankles or feet, or sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as Inflectra. Some of these cases have been fatal. All patients should be screened for signs of an infection and a hepatitis B expert should be consulted if a patient tests positive for hepatitis B surface antigen.
There have been rare cases of serious liver injury in people taking infliximab, some fatal. Patients should tell their doctors if they have liver problems and contact their doctors immediately if they develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.
Blood disorders in people taking Inflectra have been reported, some fatal. Patients should tell their doctors if they develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking Inflectra. Nervous system disorders have also been reported. Patients should tell their doctors if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, tingling, visual disturbances or seizures while taking Inflectra.
Allergic reactions, some severe have been reported during or after infusions with infliximab. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Inflectra should not be administered to patients with known hypersensitivity to Inflectra or any component of Inflectra. Patients should tell their doctors if they have experienced a severe allergic reaction. The most common side effects of Inflectra are: viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Hospira, Inc. is a global leader in biosimilars, and the world's leading provider of injectable drugs and infusion technologies. 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.
Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira's biosimilars program and approval in Europe of Inflectra. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on the company's quality initiatives and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, legal, technological, manufacturing supply, quality, modernizing and streamlining activities, and 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 and subsequent Quarterly Reports on Forms 10-Q, 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 Sokka T. Clinical experience with infliximab biosimilar – switch from Remicade. Abstract SAT0174. Presented June 2015 at EULAR, Rome, Italy. Available at https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252112
2 Park W, Yoo D H, Suh C H et al. Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433. Presented June 2015 at EULAR, Rome, Italy. Available at https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=256121
3 Putrik P, Ramiro S, Kvien TK et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014. Jan; 73(1): 198-206.
4 Brodszky V., Baji P., Balogh O and Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ (2014) 15 (Suppl 1):S65–S71.
5 Merck and Co, 2013 Annual Report, available from: http://www.merck.com/investors/financials/form-10-k-2013.pdf. Accessed May 2015.
6 Hospira, Inc., 2014, Data on file.
7 European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. Available at http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf Accessed May 2015.
8 Inflectra (infliximab). Summary of Product Characteristics. 2014.
SOURCE Hospira, Inc.