LEAMINGTON SPA, England,
June 28, 2013 /PRNewswire/ -- Hospira
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, today received a positive opinion from the
European Medicines Agency (EMA) Committee for Medicinal Products
for Human Use (CHMP), recommending the European Commission (EC)
approval of Inflectra (infliximab) for rheumatoid arthritis,
inflammatory bowel disease and plaque psoriasis.
Inflectra (infliximab) is a biosimilar medicine to the reference
medicinal product, Remicade® (infliximab), and is the
first monoclonal antibody therapy to reach a positive opinion
following review via the EMA biosimilars regulatory pathway. A
biosimilar developed in-line with EU requirements can be considered
a therapeutic alternative to an existing biologic, with comparable
quality, efficacy and safety to the reference product.[1]
Remicade® had European sales of over USD 2bn in 2012.[2]
"Today's announcement is confirmation that Inflectra has met the
very rigorous quality, safety and efficacy requirements that have
been established by the EMA, and provides the next step toward
Inflectra being approved for use in Europe," said Dr. Stan
Bukofzer, Corporate Vice President and Chief Medical
Officer, Hospira.
Biologic medicines have led to vast improvements in the
treatment of conditions such as rheumatoid arthritis and
inflammatory bowel disease, but they also represent one of the
biggest medical expenditures in many countries.[3]
"In a time when there is mounting pressure on healthcare budgets
worldwide, Inflectra provides an opportunity to increase patient
access to more affordable biologic therapy while maintaining high
quality standards," said Richard
Davies, Senior Vice President and Chief Commercial Officer,
Hospira.
Inflectra specifically targets tumour necrosis factor (TNF)
alpha, a protein in the body that contributes to the painful
inflammation seen in rheumatoid arthritis, inflammatory bowel
disease and plaque psoriasis. The drug's safety, efficacy and
tolerability have been established through a comprehensive clinical
trial programme. In a phase III randomised, double-blind study,
Inflectra met its primary endpoint of therapeutic equivalence to
the reference product. In the study, 73.4% of patients receiving
Inflectra achieved a greater than 20% improvement in RA symptoms
after 30 weeks of treatment (using the ACR20 scoring system),
compared with 69.7% treated with reference infliximab. The safety
and tolerability of Inflectra was also demonstrated to be
comparable to Remicade, supporting its approval.[4]
In 2009, Hospira entered into an agreement with South
Korean-based biopharmaceutical company, Celltrion, which is
developing eight monoclonal antibody biosimilars. Under the terms
of the agreement, Hospira obtained the rights to Inflectra in
Europe, the United States, Canada, Australia and New
Zealand.
The European Commission reviews the recommendations of the CHMP.
The final decision on approval, usually granted within three months
of CHMP opinion, will be applicable to all European Union (EU) and
European Economic Area (EEA) countries.
Hospira has many years of experience in the field of biologics
and one of the largest biosimilar pipelines in the industry. It is
the only U.S.-based company with biosimilars on the European
market, including Retacrit™ which was launched
in Europe in early 2008 and Nivestim™, which entered the
European market in 2010 and Australian market in 2011.
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., and has approximately
16,000 employees. Learn more at www.hospira.com.
The head office for Hospira in Europe, Middle
East and Africa is in
Leamington Spa, UK.
References
[1] Weise M. et al. Blood. 2012; 120: 5111-5117
[2] Merck and Co, 2012 Annual Report, available from:
http://www.merck.com/investors/financials/annual-reports/. Accessed
June 2013.
[3] Bendtzen, K. Immunotherapy. 2012; 4(11):
1167-1179.
[4] Hospira Inc, 2013, Data on file.
SOURCE Hospira, Inc.