Comparable, safety and efficacy of first mAb biosimilar therapy confirmed by TGA and PBAC
Melbourne, Australia, Aug. 21, 2015 –The PBAC today recommended that InflectraTM (infliximab),1 the first monoclonal antibody 'mAb' biosimilar registered in Australia, be added to the Pharmaceutical Benefits Scheme (PBS). The recommendation is the first step towards unlocking greater savings for Australia's health system which currently spends more than $100 million annually on a comparable therapy.2
Inflectra will be used in hospitals and was registered by the Therapeutic Goods Administration (TGA) this week for the treatment of eight inflammatory conditions: rheumatoid arthritis (RA); psoriatic arthritis; ankylosing spondylitis (AS); adult and paediatric Crohn's disease; adult and paediatric ulcerative colitis; and plaque psoriasis.1
The registration and reimbursement recommendation for Inflectra are underpinned by extensive data, including the results of clinical trials in patients with RA and AS which support that Inflectra is biosimilar to Remicade®.
Hospira said it was pleased that both the TGA and PBAC independently reviewed the scientific evidence and determined that the quality, safety and efficacy of Inflectra were comparable to that of Remicade®.
Wayne Lee, Associate Director, Medical Affairs, for Hospira said that "Patient wellbeing is our number one priority. We will continue to work constructively with the Department of Health to finalise the details and date for a PBS listing. This is a positive step for those living with these chronic diseases. In Australia and around the world, biosimilars can increase patient access to these biologic medicines. Every dollar saved by a hospital using Inflectra may be used to pay for other therapies – that's a win for healthcare providers and their patients."
Inflectra received its authorisation from the European Medicines Agency in September 2013 for all of the licensed indications of Remicade®. Inflectra is now available in 26 European countries. The biosimilar therapy was approved for use in Australia by the TGA on 19 August 2015 for the same suite of indications as Remicade®.
A biosimilar is a biologic medicine that has been researched and developed in line with the high quality standards of biologic manufacturing to deliver similar safety and efficacy profile as the originator product. A biosimilar has the potential to deliver a 20-30 per cent reduction in the price paid for these biologics.
With a number of originator biologic medicines (primarily mAb therapies) set to come off patent, the Federal Government estimates that increased use of biosimilar medicines will deliver $880 million in PBS savings over the next five years.3
Hospira has a robust biosimilar pipeline and has already delivered more than 10 million doses of biosimilar medicines to patients worldwide,4 including many cancer patients in Australia who receive treatment with Nivestim™, a filgrastim biosimilar, for neutropenia.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. 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, Illinois, USA. Learn more at www.hospira.com.
About Hospira ANZ
Hospira is an essential part of the Australian health system with every major Australian hospital using its medicines. Hospira supplies more than 15 percent5 of all sterile injectable medicines used in Australian hospitals. Hospira has significant heritage in Australia and New Zealand dating back to 1845 when FH Faulding opened a pharmacy in Adelaide.
Hospira is a specialty hospital pharmaceutical company offering sterile injectable pharmaceuticals, infusion devices and acute-care pharmaceuticals. Through these highly specialised products, Hospira ANZ offers unique solutions to the challenges faced by healthcare professionals in their clinical practice. Hospira ANZ has offices in Melbourne, Sydney and Wellington, and manufacturing and research and development sites in South Australia and Victoria. Learn more at www.hospira.com.au.
Hospira. Inflectra Australian Product Information 2015
PBS Data, 2014
The Hon. Sussan Ley, Minister for Health Media Release. Pharmaceutical Benefits Scheme to be reformed. 27 May 2015. Available at: http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley063.htm?OpenDocument&yr=2015&mth=05
Hospira, Inc., 2015, Data on file
IMS Data July 2015
Remicade® is sponsored by JANSSEN CILAG Pty Ltd in Australia.
INFLECTRA™ (infliximab) MINIMUM PRODUCT INFORMATION
Please review Full Product Information before prescribing.
Indications: Rheumatoid arthritis in adults (with methotrexate); ankylosing Spondylitis; refractory psoriatic arthritis in adults; refractory moderate to severe plaque psoriasis in adults; moderate to severe Crohn's disease in adults and children 6 years of age and older including refractory fistulising Crohn's disease in adults; refractory moderately severe to severe active ulcerative colitis in adults and children 6 years of age and over. Dosage: Complex, refer to full PI. Generally, initial dose is 3-5 mg/kg given as an intravenous infusion over a 2-hour period depending on the indication. Observe patient for at least one to two hours post infusion for side effects. Contraindications: Severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections; hypersensitivity to infliximab, murine proteins or to any excipient of the product; concurrent anakinra; congestive heart failure. Precautions: Infusion and hypersensitivity reactions - observe for at least one to two hours post infusion for side effects; antibodies may develop; malignancy including leukaemia, lymphoma, melanoma, skin cancer (periodic skin examination recommended), colon cancer/dysplasia history or risk; moderate to severe COPD; monitor for lupus-like syndrome; acute suppurative fistula; history of chronic or recurrent infection; increased risk of infection, including respiratory tract and urinary tract, TB, viral and fungal (monitor for up to 6 months post-treatment); pretreatment risk evaluation of TB, HIV, Hepatitis B and C; surgery; children < 6 years (Crohn's disease, ulcerative colitis), less than or equal to 17 years (other indications); congestive heart failure; Use in pregnancy: not recommended; Use in lactation: not recommended, including at least 6 months post treatment; Interactions: abatacept; anakinra (contraindication); live vaccines; therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation) Adverse effects: Infusion-related reactions including dyspnoea, urticaria, hypotension, flushing and headache; anaphylactic reaction (rare); delayed hypersensitivity; viral infection (e.g., influenza, herpes infections); fever; serum-sickness-like reactions; vertigo/dizziness; infections including opportunistic, upper and lower respiratory tract infection; gastrointenstinal reactions including nausea; diarrhoea, abdominal pain, constipation, gastroesophageal reflux, cheilitis; cholecystitis; rash; pruritus; increased sweating; dry skin; oedema, hot flashes;pain; blood dyscrasias; demyelinating disorders; lymphoma, melanoma (rare); autoantibodies / lupus-like syndrome; elevations of ALT and AST; others, See full PI.
Full Product Information is available on request from Hospira Pty Ltd. (ABN 13 107 058 328) Level 3, 500 Collins St, Melbourne, Victoria, 3000, Australia. ZolV1.0 0215
PBS Information: Inflectra is not listed on the PBS
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 US 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.
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