Hospira, Inc. has just announced its leading monoclonal antibody (mAb) biosimilar therapy, Inflectra, is now registered in Australia as a treatment of 8 inflammatory diseases, including: rheumatoid arthritis (RA); psoriatic arthritis; ankylosing spondylitis (AS); adult and pediatric Crohn’s disease; refractory fistulising Crohn’s disease; adult and pediatric ulcerative colitis; and plaque psoriasis. The registration step in Australia allows the Federal Government to reduce the cost of some of the more expensive drugs on the Pharmaceutical Benefits Scheme (PBS).
Inflectra is Hospira’s biosimilar formulation of Janssen Pharmaceuticals’ Remicade (infliximab), which is estimated to have cost the PBS over $100 million in 2014 alone. With the addition of a Remicade biosimilar to the PBS, more Australians suffering from an inflammatory condition can now gain access to treatment that is clinically on par, if not superior, to the branded medication at a fraction of the cost.
The Therapeutic Goods Administration of Australia approved Inflectra based on the positive findings of several pivotal studies in patients with rheumatoid arthritis and ankylosing spondylitis, which exhibited the drug’s therapeutic similarity 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,” he added.
The Federal Government of Australia is foreseeing an increase in approved biosimilars as many original biologic medicines approach the end of their patent coverages. The increased use of biosimilar medicines is expected to produce $880 million in PBS savings for the next 5 years.
“Biosimilars increase access to medicines and we look forward to working with the Government and prescribers to ensure the full benefits of biosimilars are realised in Australia,” Mr Lee concluded.