Updated on 20 August 2015
Hospira's Inflectra (infliximab), a monoclonal antibody gets registered in Australia
Singapore: Hospira's Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia in govern,emt's response to reduce the cost of healthcare in Australia.
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.
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.
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.
"Inflectra offers comparable efficacy, safety and quality as the reference product, with the potential for sizeable cost savings," said Mr 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.