20th August 2015.
The Generic and Biosimilar Medicines Association (GBMA) welcomes the approval of biosimilar infliximab, Inflectra®. Inflectra is the first biosimilar infliximab to be approved in Australia, providing an alternative, affordable treatment option for patients suffering from a range of diseases including rheumatoid arthritis, psoriasis, ulcerative colitis and Crohn’s disease.
A biosimilar is a biological medicine that is determined 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.
“The approval of biosimilar infliximab is great news for patients as it provides an additional treatment option for those living with some of the most debilitating autoimmune diseases and will create savings allowing greater access to newer, more expensive medicines,” said GBMA CEO, Belinda Wood.
“Importantly, the approval of biosimilar infliximab increases the TGA’s experience in appropriately evaluating biosimilars, including extrapolating indications from the reference biological medicine. This is essential if Australia is to unlock the full value offered by biosimilars,”
“Biosimilar infliximab is the first of a number of biosimilars currently under development. Over the coming years, we can expect approval of biosimilar versions of some of the most commonly prescribed, and costly, biological medicines on the Pharmaceutical Benefits Scheme (PBS),”
With brand-name biological medicines now accounting for $2.3 billion, or around 25% of annual PBS expenditure, the increased availability of biosimilars is expected to deliver significant savings to the PBS.
“We are entering a new era of affordable medicines with biosimilars. The availability, and PBS listing, of biosimilars will mean the government can afford to pay for more patients to 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,” she said.
GBMA now looks forward to the PBS listing of Inflectra, and anticipates a recommendation on this issue will be included in the outcomes of the July PBAC meeting, expected later this week.