Hospira Says TGA Approves First Monoclonal Antibody Biosimilar

(RTTNews) - Hospira (HSP) said that Inflectra or infliximab, the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. The registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme or 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.

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

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.

Inflectra received its authorization from the European Commission in September 2013 for all the licensed indications of Remicade. Inflectra is now available in 26 European countries.