Registration of Hospira’s infliximab biosimilar, Inflectra, marks the first approval of a biosimilar monoclonal antibody by the Therapeutic Goods Administration. In order to achieve this approval Inflectra has demonstrated that it is biosimilar to the blockbuster drug, Remicade.

The PBAC subsequently listed Inflectra for the same indications as Remicade which is used in 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.

The PBAC granted Inflectra ‘a-flagging’ status only a couple of months after the introduction of this controversial legislation. A-flagging means that pharmacists are allowed to switch patients to approved biological medicines; in this case from Remicade to Inflectra or vice versa. The introduction of biosimilar drugs is expected to provide significant cost saving for the PBAC – especially given that the cost of infliximab prescriptions in 2014 was close to $70 million.

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