Biosimilar infliximab now approved in Australia

August 21, 2015 12:25 PM

The PBAC today recommended that Inflectra, the first monoclonal antibody biosimilar registered in Australia, be added to the Pharmaceutical Benefits Scheme (PBS).

The recommendation is the first step towards savings for Australia’s health system which currently spends more than $100 million annually on a comparable therapy.

Biosimilar infliximab will be used in hospitals and was registered by the Therapeutic Goods Administration (TGA) this week for the treatment of eight inflammatory conditions: rheumatoid arthritis (RA); psoriatic arthritis; ankylosing spondylitis (AS); adult and paediatric Crohn’s disease; adult and paediatric ulcerative colitis; and plaque psoriasis.

The registration and reimbursement recommendation for Inflectra are underpinned by extensive data, including the results of clinical trials in patients with RA and AS which support that Inflectra is biosimilar to Remicade.

Hospira said it was pleased that both the TGA and PBAC independently reviewed the scientific evidence and determined that the quality, safety and efficacy of Inflectra were comparable to that of Remicade.

Wayne Lee, Associate Director, Medical Affairs, for Hospira said that “Patient wellbeing is our number one priority. We will continue to work constructively with the Department of Health to finalise the details and date for a PBS listing. This is a positive step for those living with these chronic diseases. In Australia and around the world, biosimilars can increase patient access to these biologic medicines. Every dollar saved by a hospital using Inflectra may be used to pay for other therapies – that’s a win for healthcare providers and their patients.”

 

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