Archives for August 2015

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.

21st August 2015.

The Generic and Biosimilar Medicines Association (GBMA) welcomes the recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list biosimilar infliximab (Inflectra®) on the Pharmaceutical Benefits Scheme (PBS). GBMA also welcomes the PBAC decision to recommend the marking as equivalent, also known as “a” flagging, of Inflectra with the reference product, Remicade®.

The PBAC is an independent expert body appointed by the Australian Government, whose members include doctors, health professionals, health economists and consumer representatives. Its primary role is to make recommendations to the Minister for Health on the government’s $10 billion annual PBS budget.

“PBS savings and improved patient access can only be realised if the use of biosimilars is supported by drivers to encourage uptake by doctors, pharmacists and patients. The decision to apply an “a” flag to a biosimilar in the Schedule of Pharmaceutical Benefits is an uptake driver that will enable a pharmacist to substitute the biosimilar for the reference biological medicine in exactly the same way as generic medicines,” said GBMA CEO Belinda Wood

“The PBAC has stated it would consider “a” flagging of biosimilars on a case-by-case basis. Healthcare professionals and patients should therefore be reassured that the PBAC has taken an evidence-based approach in making this recommendation,”

“It is important to note that even with “a” flagging of biosimilars, doctors retain prescribing control and the ability to tick the ‘no substitution’ box on prescriptions. Patients also retain the right to choose a biosimilar at the pharmacy,”

“The recommendation for PBS listing of biosimilar infliximab recognises the important role biosimilars play in supporting PBS affordability today and in the future,”

“Australian patients will benefit from more affordable biosimilars and, as a result of competition, the PBS savings expected to be generated from the PBS listing of these biosimilars can provide an opportunity to improve patient access to life-changing medications,” she said.

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.

3 August 2015.

Allan Tillack has accepted the position of Chair of the Generic and Biosimilar Medicines Association (GBMA), effective today.

Mr. Tillack has been the Sandoz Country Head for Australia and New Zealand since December 2013 and has a long history in the Australian pharmaceutical industry with prior commercial roles at Abbot Nutrition, Alphapharm, Monsanto and Astra. He previously held the position of GMiA Deputy Chair from July 2013 and together with the then Chair, Mr. Mark Crotty, secured a strategic agreement with the government to support the sustainability of the generic and biosimilar medicines industry in Australia, and deliver a 5-year period of certainty.

“The sustainability of our sector and the ongoing supply of affordable medicines is of paramount importance in the provision of quality health care to Australians. It’s an exciting time for the generics and biosimilars industry. We are ideally positioned to work with key stakeholders to deliver on tangible measures that directly address both access to and the affordability of high quality medicines to the patients that need them. Achieving this ambition will require developing a framework that supports and secures the viability of our industry.” Mr. Tillack said.

“Under the National Medicines Policy and through our Strategic Agreement, I will continue to engage with government proactively to ensure a future where fair pricing of affordable medicines meets the needs of patients, government and industry,”

“The GBMA today is a strong, focused organisation and I will build upon the important work done by my predecessor, Mark Crotty. We will deliver tangible benefits from the Strategic Agreement to deliver a sustainable generic and biosimilar medicines sector,” he said.

Stephen Fraser has accepted the role of Deputy Chair. He is the Managing Director ANZ at Alphapharm-Mylan and has been on the Board of GBMA since July 2013. Working closely with the Chair, Mr. Fraser will ensure the outcomes of the Strategic Agreement will result in the ongoing supply of affordable medicines and the viability of the industry that supplies them.

ENDS