Hospira launches first biosimilar monoclonal antibody Inflectra (infliximab) in major European markets
Hospira, Inc., a world leader in the development of biosimilar therapies, has 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 Europei 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.ii Inflectra can offer a cost-effective alternative while maintaining the same quality, safety and efficacy as the reference product.iii, iv
“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.v 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.iii
Remicade (infliximab) has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013.vi 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.vii
“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 licence 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.viii 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.viii 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.viii
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.ix
[i] Bendtzen, K. Anti-TNF-? Biotherapies: Perspectives for Evidence-Based Personalized Medicine. Immunotherapy. 2012; 4(11): 1167-1179.
[ii] 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.
[iii] Weise M, Bielsky MC, Smet K et al. Biosimilars: what clinicians should know. Blood. 2012; 120: 5111-5117.
[iv] 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 February 2015.
[v] 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.
[vi] Merck and Co, 2013 Annual Report, available from: http://www.merck.com/investors/financials/form-10-k-2013.pdf. Accessed January 2015.
[vii] Haustein R, Millas C, Höer A et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal. 2012; 1(3-4): 120-6.
[viii] 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/medicines/002778/human_med_001677.jsp Accessed January 2015.
[ix] Hospira, Inc., 2014, Data on file.
[x] Inflectra (infliximab). Summary of Product Characteristics. 2014.
Source: Hospira, Inc.