TGA Approves First mAb Biosimilar

Hospira has announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (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)1 — 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 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 said.

With a number of originator biologic medicines (primarily mAb therapies) set to come off patent, the Federal Government in Australia estimates that increased use of biosimilar medicines will deliver $880 million in PBS savings over 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 added.