10 November 2015.

Four policy priorities that will safeguard affordable access to medicines in Australia while ensuring the generic and biosimilar medicines industry remains viable have been agreed to by the Federal Government.

The Generic Medicines Working Group (GMWG), which was established under the Strategic Agreement signed by the Minister for Heath, Hon Sussan Ley and the Generic and Biosimilar Medicines Association (GBMA) in May 2015, has identified four policy priorities that have been endorsed by the Minister. The four policy priorities relate to:

1. Pricing policy, supply and industry viability
2. Uptake drivers for generic and biosimilar medicines
3. Biosimilar medicines – patient access and utilisation
4. Transparency of PBS processes

Under the Strategic Agreement between the Commonwealth and the GBMA, both parties will work together to identify and implement initiatives to support the ongoing sustainability of the generic medicines sector.

“GBMA and the Government have a common interest in the ongoing and reliable access to affordable generic medicines and biosimilars, a strong Pharmaceutical Benefits Scheme (PBS) that can meet the current and future needs of Australians, and having a sustainable generic medicines sector,” said GBMA Chairman, Allan Tillack.

“Generic medicines and biosimilars play an essential role in delivering affordable healthcare through the PBS. However, some medicines are now supplied for less than the cost of a cup of coffee and this unsustainable pricing is resulting in medicines being removed from the PBS, impacting supply for patients,” he said.

“The viability of our sector and the ongoing supply of affordable medicines are of paramount importance to the provision of quality healthcare to Australians. It is essential that industry and the government work together through the GMWG to deliver tangible solutions that directly address patient access and affordability of high quality medicines, while securing the ongoing viability of the industry that supplies them,” Mr. Tillack said.

ENDS

6 October 2015.

The Generic and Biosimilar Medicines Association (GBMA) welcomes the news that Australia has not agreed to extend the data exclusivity period for medicines in the finalisation of the Trans Pacific Partnership Agreement (TPP).

Initial reports indicate that the Australian Government has recognised that the current system of data protection adequately balances innovation for new medicines with market access for affordable medicines and that it has deflected international pressure to move from that position. The fact is, the longer the term of data exclusivity granted by a country, the longer that country will be without generic versions of patent-expired medicines and the longer patients will have to wait for affordable access to the latest therapies.

“It is so important that Australian patients have ongoing access to affordable medicines through the Pharmaceutical Benefits Scheme (PBS). Pressure from the US to extend Australia’s current 5-year data exclusivity period in the TPP would only delay market access for generic and biosimilar medicines, unnecessarily delay the realisation of savings to the PBS, and delay patient access to affordable medicines,” said GBMA CEO Belinda Wood

“We are encouraged by the strong stance taken by the Australian Government in the TPP negotiations. Trade Minister Robb has put the needs of Australian patients ahead of the interests of US-based brand name medicine companies,”

“The finalisation of the TPP without an extension to data exclusivity means Australian patients will continue to have timely access to affordable generic and biosimilar medicines. However, when it comes to trade agreements, the devil is in the detail and we await the public disclosure and scrutiny of the agreed final text,” she said.

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.