infliximab the first biosimilar monoclonal antibody to be approved
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. 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 responsibpatagonia outlet new york cityle 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 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 quality, efficacy and safety its reference product. We are confident that with lower drug costs, Inflectra can provide an opportunity for European Union health systems to manapatagonia guide jacket logos1ge 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 endpopatagonia baggies light reviewint 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 wpatagonia store zuricheeks 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, hepatagonia guide jacket logos3adache, upper respiratory tract infection, sinusitis, nausea, abdominal pain, infusion related reactions and pain.In 2009, Hospdiscount patagonia nano puff pulloverira 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 early 2008 and Nivestim (filgrastim), which entered the European market in 2010 and Australian market in 2011.About InflectraInflectra (infliximab) is a chimeric human monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF but not to lymphotoxin (TNF 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. Infliximab has been studied only in combination with conventional immunosuppressive therapy.Ulcerative colitisInpatagonia guide jacket logos2flectra 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 (6 or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.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 administeredin combination with methotrexateor 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 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).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 commpatagonia guide jacket logos0on.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 havpatagonia discount code xeroxe 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 inpatagonia guide jacket logosfliximab, 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, spatagonia guide jacket 30ome 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, tinglinpatagonia guide pants offg, 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 theypatagonia isthmus parka buy have experienced a severe allergic reaction. The most common side effects of INFLECTRA are: viral infections, headache, upper respiratory tract infection, sinusitis,patagonia military clothing for sale nausea, abdominal pain, infusion related reactions and pain.
