Hospira has announced that Inflectra, (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). A biosimilar is a biologic medicine that has been developed to treat the same diseases as the originator product and the marketing hope is that it will deliver a 20-30 percent reduction in the price paid for the therapy.

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) 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.

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

"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."

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)


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/healt...
Hospira, Inc., 2015, Data on file