IBD Biosimilar Inflectra Approved by TGA

IBD Biosimilar Inflectra Approved by TGA

Patient advocacy groups and the biotech industry are heralding the development and approval of biosimilars as a new day for the Inflammatory Bowel Disease’s (IBD) treatment. After the launching of the first Biosimilar Monoclonal Antibody in Europe in February and the presentation of promising research updates on the biosimilar Inflectra at the 2015 ECCO-IBD Conference,  Hospira is now announcing that Inflectra (infliximab) has been registered as a therapy in Australia. A total of eight inflammatory conditions can be treated with Inflectra, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), adult and pediatric Crohn’s disease, refractory fistulising Crohn’s disease, adult and pediatric ulcerative colitis, and plaque psoriasis.

Inflectra is an artificial compound that is biologicaly similar to Remicade® (infliximab). As a biosimilar, Inflectra has been developed to mimic the high standards of biologic manufacturing to treat the same disease as the original product. Moreover, it is anticipated that Inflectra will reduce the cost of the original therapy up to 30%. Inflectra was designed to have the same efficacy, safety and quality as Remicade, the original (and considerably more expensive) monoclonal antibody (mAb). Last year, more than $100 million was invested by the pharmaceutical industry in the production of Remicade.

The registration of the biosimilar as part of the Australian Therapeutic Goods Administration (TGA) opens up the opportunity for the Federal Government to reduce the cost the medicines. “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,” said Wayne Lee, Associate Director of Medical Affairs at Hospira.

The Australian Government expects that during the next five years the market of biosimilar medicines will expand due to the number of original therapies that are set to see their patents expire. This growth is estimated to deliver $880 million in Pharmaceutical Benefits Scheme (PBS) savings. In fact, Mr. Lee underscores how biosimilars can increase populations’ access to medicines due to their lower cost, and that Hospira will cooperate with the Government and prescribers in order to ensure that all Australians are aware of the benefits of using biosimilars.

Hospira has delivered more than 10 million doses of biosimilar medicines worldwide and specializes in developing biosimilar compounds for different pathologies.

Inflammatory Bowel Disease describes a group of inflammatory conditions of the colon and the intestine due to an abnormal response to the body’s immune system. The two most common inflammatory bowel diseases are ulcerative colitis and Crohn’s disease.