The department of health has issued a fact sheet to prescribers and pharmacists following the listing of the first biosimilar infliximab (Inflectra^®).

The Q&A style fact sheet explains the difference between Remicade^® and its biosimilar Inflectra^®, as well as the rationale behind allowing substitution at the pharmacy level (a-flagging).

Biosimilars do the same thing as the reference medicine, that is, they provide the same health outcomes, the fact sheet states.

“Because these medicines contain large, complex molecules, there can be slight differences between brands as a result of differences in manufacturing.”

“This is why they are considered similar, not the same.  However, small differences can also occur between batches of the same brand of a biological medicine when the manufacturer changes a manufacturing process or facility,” it says.

Directly addressing the issue of substitution the fact sheet goes on to state that data from clinical trials showed that the two biologicals had comparable safety and efficacy.

“Where changing from Remicade^® to Inflectra^® occurred, the data indicated no difference in efficacy, safety, or immunogenicity between the biosimilar and reference biological,” it said.

The listing of a biosimilar provides patients and prescribers with a choice of brands and introduces competition, which can reduce the cost of the medicine to the health system, the fact sheet concludes.

“The listing of the first biosimilar of infliximab has already triggered a reduction in the price Government pays for this medicine.”

To read a copy of the fact sheet click here