TGA Approves First mAb Biosimilar

MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ -- Hospira today announced that Inflectra^TM (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia.  This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS).

Inflectra has been registered in Australia for the treatment of eight inflammatory conditions: rheumatoid arthritis (RA); psoriatic arthritis; ankylosing spondylitis (AS); adult and paediatric Crohn's disease; refractory fistulising Crohn's disease; adult and paediatric ulcerative colitis; and plaque psoriasis.¹

Inflectra is a biosimilar medicine formulated to deliver comparable efficacy, safety and quality as the originator biologic, Remicade^® (infliximab)¹ – a mAb therapy that cost the PBS more than $100 million last year.²

A biosimilar is a biologic medicine that has been researched and developed in line with the high quality standards of biologic manufacturing to treat the same diseases as the originator product. A biosimilar has the potential to deliver a 20-30 per cent reduction in the price paid for the therapy.

The TGA approval of Inflectra is based on extensive data, including the results of pivotal trials in patients with RA and AS which concluded that the biosimilar was therapeutically comparable to Remicade^®.¹ 

"Inflectra offers comparable efficacy, safety and quality as the reference product, with the potential for sizeable cost savings," said Wayne Lee, Associate Director, Medical Affairs, Hospira.

"Registration of Inflectra by the TGA shows that they support the fundamental principles of data extrapolation which allows patients and healthcare professionals to access the full suite of indications. This is an important development for patients, prescribers and payers," he said.

With a number of originator biologic medicines (primarily mAb therapies) set to come off patent, the Federal Government in Australia estimates that increased use of biosimilar medicines will deliver $880 million in PBS savings over the next five years.³

"Biosimilars increase access to medicines and we look forward to working with the Government and prescribers to ensure the full benefits of biosimilars are realised in Australia," Mr Lee added.

Hospira has one of the largest biosimilar pipelines in the industry 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 neutropaenia.

About Inflectra
Inflectra received its authorization from the European Commission (EC) in September 2013 for all the licensed indications of Remicade^®. Inflectra is now available in 26 European countries.

About Hospira
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 15 percent 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.

References

1. Hospira. Inflectra Australian Product Information 2015
2. PBS Data, 2014
3. 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
4. Hospira, Inc., 2015, Data on file

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

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 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.

SOURCE Hospira, Inc.

Related Links

http://www.hospira.com