27 April 2015.
The Generic Medicines Industry Association (GMiA) welcomes the decision of the Pharmaceutical Benefits Advisory Committee (PBAC) to consider “a” flagging of biosimilars, and to list biosimilar insulin (Basaglar®) on the Pharmaceutical Benefits Scheme (PBS). Basaglar is the first biosimilar insulin to be approved in Australia, providing an alternative, affordable treatment option for patients suffering from diabetes.
A biosimilar is a biological medicine that is approved to be comparable in quality, safety, and efficacy to the reference biological medicine following a full evaluation by the Therapeutic Goods Administration (TGA). Biosimilars offer therapeutically equivalent and more cost-effective alternatives to existing, high-cost biological medicines.
“Australian patients are now able to benefit from more affordable biosimilars and, as a result of competition, the PBS savings expected to be generated from biosimilars can provide an opportunity to improve patient access to life-changing medications,” said GMiA CEO Belinda Wood
“The availability, and PBS listing, of biosimilars means more patients can be treated within the same budget. However, savings can only be realised if more affordable biosimilars are listed on the PBS, prescribed by doctors and dispensed by pharmacists.”
“GMiA welcomes the PBAC decision to consider the marking as equivalent, also known as “a” flagging, of biosimilars and their reference products on a case-by-case basis,” said Ms. Wood
The decision to apply an “a” flag to a biosimilar in the Schedule of Pharmaceutical Benefits will enable a pharmacist to substitute the biosimilar for the reference biological medicine in exactly the same way as generic medicines.
