17 December 2016
The Generic and Biosimilar Medicines Association (GBMA) welcomes a recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC) to list Renflexis® on the Pharmaceutical Benefits Scheme (PBS) and looks forward to it becoming widely available to patients next year.
Renflexis is the second biosimilar infliximab to be approved in Australia, providing an alternative, affordable treatment option for patients living with a range of diseases including rheumatoid arthritis, psoriasis, and Crohn’s disease.
With Pfizer’s biosimilar Inflectra® (infliximab) gaining only three percent market share in its first year, the PBS savings from biosimilar infliximab are yet to be realised. It is through biosimilar market entry, PBS listing and competition that Australia can unlock the full value offered by biosimilars.
“The success of biosimilars in Australia will rely on physician confidence, patient awareness and policies to support uptake,” said GBMA CEO, Belinda Wood.
“With the recommendation to list the second biosimilar infliximab, ignoring the evidence in support of biosimilars is no longer an option. 10 years of biosimilar experience in Europe with over 400 million patient days has demonstrated the safety and efficacy of these medicines,”
“Additionally, clinical trials such as NOR-SWITCH and EGALITY have now demonstrated patients can be safely switched from an original brand biologic to a biosimilar with no loss of clinical effect,”
“GBMA encourages physicians to look at the evidence supporting biosimilars and take a leadership role in supporting PBS affordability through their increased use,”
“GBMA welcomes the roll out of the initial products of the biosimilar awareness initiative which will provide essential information on biosimilars for healthcare professionals, pharmacists and consumers, and looks forward to further elements of the initiative in 2017.” she said.
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BACKGROUND:
Details regarding NOR-SWITCH and EGAILTY can be obtained at: httpss://clinicaltrials.gov/ct2/home
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 TGA. Biosimilars offer therapeutically equivalent and more cost-effective alternatives to existing, high-cost biological medicines.
Previously the Generic Medicines Industry Association (GMiA), the Generic and Biosimilar Medicines Association announced a name change in July 2015 to signal the significant role the association will continue to play in the access to affordable medicines.
The Generic and Biosimilar Medicines Association is the national association representing companies that manufacture, supply and export generic and biosimilar medicines. The generic and biosimilar medicines sector is a high value-add sector delivering significant health and economic benefits to the Australian public.
The availability of generic and biosimilar medicines in this country helps to deliver:
- timely access to affordable medicines; substantial savings to the Pharmaceutical Benefit Scheme; and
- thousands of highly skilled jobs; and domestic manufacturing and exports of over $300 million
Generic and biosimilar medicines deliver the same health benefit to all Australians as the original brand and they must meet the same strict Australian standards, including the same manufacturing requirements, as branded medicines.
ENQUIRIES:
Belinda Wood M 0431 792 711
Chief Executive Officer E belinda.wood@gbma.com.au
