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Australia approves Hospira’s Inflectra biosimilar to Remicade
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Hospira announced that the Australian Therapeutic Goods Administration has approved Inflectra, its biosimilar to Remicade, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis and plaque psoriasis, and today, it was added to the country’s Pharmaceutical Benefits Scheme, according to a press release.
The decision by the Therapeutic Goods Administration (TGA) follows the results of trial with ankylosing spondylitis (AS) and rheumatoid arthritis (RA) that showed Inflectra (infliximab, Hospira) was as effective as the originator medication Remicade (infliximab, Janssen).
“Inflectra offers comparable efficacy, safety and quality as the reference product, with the potential for sizeable cost savings,” Wayne Lee, associate director of medical affairs at Hospira, said in a press release. “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.”
Access to a biosimilar could cost 20% to 30% less than the originator medication, according to Hospira’s press release. In September 2013, Inflectra was approved for use by the European Commission for all approved indications for Remicade and is now available in 26 European countries. In the U.S., the first biosimilar was approved in March for the treatment of cancer. An Arthritis Advisory Committee scheduled for March 17 slated to discuss Celltrion’s CP-P13 biosimilar to Remicade was postponed but a new date has not been announced.
Reference: http://www.hospira.com.