TGA Approves Hospira’s mAb Biosimilar

MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ — Hospira today announced that InflectraTM (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,” saidWayne 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 Australiaestimates 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

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

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