Welcome!

News Feed Item

Hospira's Inflectra™ (infliximab) the first biosimilar monoclonal antibody to be approved in Europe

-- European Commission approval is a significant milestone for availability of lower-cost biologic therapy

LEAMINGTON SPA, England, Sept. 10, 2013 /PRNewswire/ -- Hospira (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced the European Commission (EC) approval of Inflectra™ (infliximab), Europe's first biosimilar monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

Inflectra is a biosimilar medicine to the reference medicinal product, Remicade® (infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.(1) Remicade recorded European sales of over USD 2 billion in 2012.(2)

"The rigorous scientific review and approval process by the EMA and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade. For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorisation in Europe is a major milestone for Inflectra, and for the future of biologic therapy," said Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.

The use of biologic medicines has led to vast improvements in the treatment of conditions such as RA and IBD (inflammatory bowel disease), but these drugs are also responsible for some of the highest medicinal costs for many countries.(3) The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to €20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK.(4)

"Inflectra offers physicians, patients and healthcare systems a more affordable treatment option, while maintaining comparable quality, efficacy and safety to its reference product. We are confident that with lower drug costs, Inflectra can provide an opportunity for European Union health systems to manage their budgets more effectively, supporting Hospira's commitment to provide patients with better access to high-quality, more affordable care," said Richard Davies, Senior Vice President and Chief Commercial Officer, Hospira.

Inflectra was approved by the EC following review of safety, efficacy and tolerability data from a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In the study, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR20 scoring system), compared with 69.7% treated with Remicade.(5)  Safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. The most common side effects are viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.

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 and certain CIS (Commonwealth of Independent States) countries, the United States, Canada, Australia and New Zealand. Inflectra will be launched throughout Europe at the earliest opportunity taking into account any relevant patent protection.

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 US-based company with biosimilars on the European market, including Retacrit™ (epoetin zeta) which was launched in Europe in early 2008 and Nivestim™ (filgrastim), which entered the European market in 2010 and Australian market in 2011.

About Inflectra
Inflectra (infliximab) is a chimeric human‑murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ). 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).

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., 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.

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 Forms 10-Q, filed with the 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.

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) Haustein R. et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal. 2012; 1(3-4): 120-6.
(5) Hospira, Inc., 2013, Data on file.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Infranics will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Since 2000, Infranics has developed SysMaster Suite, which is required for the stable and efficient management of ICT infrastructure. The ICT management solution developed and provided by Infranics continues to add intelligence to the ICT infrastructure through the IMC (Infra Management Cycle) based on mathemat...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in ...
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
"Peak 10 is a national cloud data center solutions managed services provider, and part of that is disaster recovery. We see a growing trend in the industry where companies are coming to us looking for assistance in their DR strategy," stated Andrew Cole, Director of Solutions Engineering at Peak 10, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...