Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra (infliximab) in major European markets

-- Major European markets can finally benefit from the availability of Inflectra following the patent expiry of reference product Remicade® (infliximab)
-- Inflectra provides an alternative, potentially more affordable treatment option for people suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease while maintaining comparable quality, efficacy and safety to the reference product
-- As a result of competition, the large savings expected to be generated with biosimilars can provide an opportunity to improve patient access to life-changing medications

LAKE FOREST, Ill., Feb. 16, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis and plaque psoriasis.

Biologic medicines have transformed the lives of people living with chronic inflammatory conditions, such as RA and inflammatory bowel disease (IBD). However, biologics are responsible for some of the biggest medicinal costs across Europe1 and these high costs can restrict access to treatment. For example, it has been estimated that 40% of RA patients in Europe have severely restricted access to biologic treatment.2 Inflectra can offer a cost-effective alternative while maintaining the same quality, safety and efficacy as the reference product.3,4

"With more and more people living with chronic inflammatory diseases like RA, we need to find more cost-effective treatment solutions without compromising on quality, safety or efficacy. Biosimilars could offer one such solution – savings could mean we can treat more patients within the same healthcare budget," said Professor Josef Smolen, Chairman of the Division of Rheumatology at Medical University of Vienna. "Biosimilars that underwent assessment and approval by the European Commission have been included in the latest EULAR treatment recommendations."

Infliximab is a cornerstone treatment for many inflammatory diseases, with over 15 years' worth of clinical data and experience.5 Inflectra is a biosimilar medicine to the reference product, Remicade® (infliximab), and is the first biosimilar mAb to be approved by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.3

Remicade (infliximab) has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013.6 The savings generated by introducing competition in the marketplace could save the European healthcare system millions of Euros, with biosimilars expected to produce savings of over €20 billion by 2020.7

"Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications. We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra. This supports Hospira's commitment to provide patients with better access to high-quality, more affordable care," said Paul Greenland, Vice President Biologics, Hospira.

Inflectra received its license from the EC in September 2013, following adoption of the EMA Committee for Medicinal Products for Human Use (CHMP) positive recommendation for granting marketing authorization. Review by the EMA included detailed analysis of biophysical properties and safety, efficacy and tolerability data from an extensive preclinical and clinical trial program.

In a phase III randomized, double-blind study involving 606 patients, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In this study, using the ACR20 scoring system, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with Remicade.8 In the same study, 42.3% of patients receiving Inflectra achieved a greater than or equal to 50% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR50 scoring system), compared with 40.6% treated with Remicade.8 Comparable safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. There were no marked differences in the immunogenicity profile of the two products up to 54 weeks, and the impact of anti-drug antibodies on efficacy and safety was comparable.8

Inflectra is being launched in several major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden. With the launch of the product in these new markets, Inflectra is now available in 24 European countries. Hospira's partner, Celltrion, has also submitted an application to the U.S. Food and Drug Administration for biosimilar infliximab.

With one of the largest biosimilar pipelines in the industry, Hospira has more than seven years' of market experience in biosimilars. 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.9

About Inflectra10

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 α (TNF beta). Inflectra is indicated for:

Rheumatoid arthritis
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 6 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.

    Ulcerative colitis
    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 6 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.

    Ankylosing spondylitis
    Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

    Psoriatic arthritis
    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.

    Psoriasis
    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.

    About Hospira
    Hospira, Inc. is 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.

    The head office for Hospira in Europe, Middle East and Africa is in Hurley, UK.

    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.

    References

    1. Bendtzen, K. Anti-TNF-alpha Biotherapies: Perspectives for Evidence-Based Personalized Medicine. Immunotherapy. 2012; 4(11): 1167-1179.
    2. 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.
    3. Weise M, Bielsky MC, Smet K et al. Biosimilars: what clinicians should know. Blood. 2012; 120: 5111-5117.
    4. 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.... Accessed February 2015.
    5. Danese S, Colombel J, Reinisch W et al. Review article: infliximab for crohn's disease treatment – shifting therapeutic strategies after 10 years of clinical experience. Alimentary Pharmacology and Therapeutics. 2011; 33: 857-869.
    6. Merck and Co, 2013 Annual Report, available from: http://www.merck.com/investors/financials/form-10-k-2013.pdf. Accessed January 2015.
    7. Haustein R, Millas C, Hoer A et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal. 2012; 1(3-4): 120-6.
    8. EMA. Inflectra European Public Assessment Report – Summary for the public. EMA/402688/2013. Available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medic... Accessed January 2015.
    9. Hospira, Inc., 2014, Data on file.
    10. Inflectra (infliximab). Summary of Product Characteristics. 2014.
    February, 2015. EMEA/INF/13/0005[2]

    SOURCE Hospira, Inc.

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