8 June 2017
Highlighting the important role of the Australian generic and biosimilar medicines industry and the Therapeutic Goods Administration (TGA) in making medicines affordable, this new report lists all generic and biosimilar medicines registered in 2016.
The Generic and Biosimilar Medicines Association (GBMA) today welcomes the release of Generic and biosimilar prescription medicines: TGA annual summary 2016, the first publicly available annual summary of all new generic and biosimilar prescription medicines registered in Australia. It complements other summaries published by the TGA on the registration of new chemical entities.
“Every new generic and biosimilar medicine approved by the TGA provides an opportunity to make medicines more affordable and accessible for Australian patients,” said GBMA CEO Belinda Wood.
The report outlines that in 2016, the TGA evaluated 114 submissions which resulted in the registration of 73 discrete active ingredients, and 20 ‘first generic’ medicines across a range of therapeutic areas.
“In 2016, new generic and biosimilar medicines were approved for a wide range of medical conditions, increasing patient access to life-changing treatments for hepatitis C, HIV, asthma, depression and cancer, just to name a few,”
“That 114 submissions were evaluated in 12 months demonstrates the importance of a competitive generic and biosimilar medicines industry in bringing these medicines to market,”
“As every ‘first generic’ approved by the TGA delivers an immediate 16% saving when listed on the Pharmaceutical Benefits Scheme (PBS), this report shows there were 20 new savings opportunities just in 2016. These savings support health innovation, medical research and development, and the sustainability of our healthcare system,”
“GBMA appreciates the vital role TGA has in ensuring the quality, safety and efficacy of all medicines registered in Australia, including new chemical entities, generic and biosimilar medicines,”
“As the TGA continually monitors the safety of prescription medicines once they become available on the market, Australian patients, prescribers and pharmacists can be confident of the quality, safety and efficacy of all generic and biosimilar medicines registered in Australia,” she said.