18 February 2015.

The Generic Medicines Industry Association (GMiA) welcomes the announcement from member company, Hospira that its biosimilar infliximab (InflectraTM) is now available in more major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden.

Inflectra is the first biosimilar monoclonal antibody to be approved in Europe. It provides a more affordable treatment option for patients suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease.

“Now, patients in these major European countries can benefit from the patent expiry of reference product Remicade® (infliximab) and, as a result of competition, the savings expected to be generated from biosimilars can provide an opportunity to improve patient access to life-changing medications.” said GMiA CEO Belinda Wood

“And this is a great sign for Australian patients. As the Therapeutic Goods Administration looks to Europe for guidance on biosimilar regulation, we look forward to Australian patients soon being able to access biosimilar infliximab.”

“Significant market entry barriers currently exist in the regulation and reimbursement, prescribing and dispensing of biosimilars. These market entry barriers need urgent attention and GMiA recommends the implementation of a clear and predictable market access pathway, with uptake drivers, for biosimilars.”

Biosimilars provide a unique opportunity to help manage the growing costs of biological medicines on the Pharmaceutical Benefits Scheme.

“Savings can only be realised if more affordable biosimilars are prescribed and dispensed. For Australia to realise all the benefits of biosimilars, it is important that market uptake drivers are implemented to encourage the use of biosimilars and the GMiA looks forward to working with Government on these.” said Ms. Wood. – ENDS-

22 December 2014.

The Generic Medicines Industry Association (GMiA) warmly welcomes the appointment of the Hon Sussan Ley as Minister for Health and looks forward to productive discussions about the issues that will secure the ongoing supply of affordable medicines and the savings that they bring to the Pharmaceutical Benefits Scheme (PBS).

“We look forward to a fresh approach from Ms Ley. It is time for new thinking when it comes to the PBS, consideration of the consequences of price disclosure, a commitment to business certainty for industry and action on a predictable market entry pathway for biosimilars,” said Mr Mark Crotty, GMiA Chairman.

GMiA also extends best wishes to outgoing Minister for Health, Peter Dutton, as he takes on the portfolio of Immigration and Border Protection.
– ENDS –

16 December 2014.

The Generic Medicines Industry Association (GMiA) Board has today announced Belinda Wood as the new GMiA CEO. Ms Wood is well known to GMiA members and stakeholders having previously held the role of GMiA Policy Director and most recently fulfilling the role of Acting CEO.

The appointment recognises both the strong contribution Belinda has made to the GMiA over several years and the significant progress she has made in critical policy areas.

“Belinda has extensive networks within the industry and in Canberra. She is respected for both her integrity and collaborative approach. The pharmaceutical industry is facing significant change and the GMiA Board believes that Belinda’s skill set will be essential to navigating this period of change collaboratively with government,” said GMiA Chair Mark Crotty.

Belinda has more than 18 years’ experience in the pharmaceutical industry and has had a strong Canberra presence since 2004. She has shaped medicines policy for the Pharmacy Guild of Australia and as a government/industry liaison and market insight consultant. Belinda holds a BMedSc in Pharmacology and currently sits on several industry committees including the Drug Utilisation Sub Committee (DUSC) and TGA Industry Working Group.

“GMiA members deliver billions of dollars in PBS savings, first by providing competition and then through price disclosure. These savings depend on the existence of a thriving generic medicines industry. However pricing pressures continue to be felt and will force increasing numbers of medicines to be delisted. The big challenge for the PBS is ensuring fair pricing that secures the supply of less expensive critical medicines along with the industry that provides them.” said Ms Wood.

“The health system is yet to achieve the full value offered by generic and biosimilar medicines. Urgent policy changes are needed to realise the health, patient access and economic benefits of biosimilar medicines. My immediate focus will be on business certainty for GMiA members, the efficient approval of generic medicines, greater utilisation of less expensive generic medicines and a predictable market access pathway for biosimilars.”

– ENDS –
For all media enquiries, please call Belinda Wood of GMiA on 0431 792 711.

The GMiA is the national association representing companies that manufacture, supply and export generic medicines. The generic medicines sector is a high value-add sector delivering significant health and economic benefits to the Australian public.
The availability of generic medicines in this country helps to deliver timely access to affordable medicines, substantial savings to the PBS, thousands of highly skilled jobs and domestic manufacturing and exports of over $400 million. Generic medicines deliver exactly 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.

24 October 2014.

The Generic Medicines Industry Association (GMiA) welcomes the government’s announcement of an expert review of medicines and medical device regulation in Australia.

GMiA acting CEO, Belinda Wood said “Today’s announcement recognises that there are efficiencies to be gained in the regulation of medicines. Improving the efficiency of the Therapeutic Goods Administration (TGA) processes will reduce duplication and the regulatory burden on medicine manufacturers, and result in Australian patients being able to access more affordable generic medicines sooner.”

GMiA members operate in the global context and recognise the work to date of the TGA to work cooperatively with regulators in other jurisdictions. Removal of Australian-specific regulatory requirements, international work-sharing and more efficient use of TGA resources will result in more efficient access to affordable medicines, encourage competition and deliver ongoing savings to the Pharmaceutical Benefits Scheme (PBS).

“With our member base supplying more than 90% of generic prescription medicines dispensed in Australia, GMiA looks forward to working with the expert panel, providing them with constructive solutions to ensure the regulatory framework balances safety and market access to benefit Australian patients.” said Ms Wood. ENDS.

17 September 2014.

The Generic Medicines Industry Association (GMiA) welcomes the visit of Minister for Industry, The Hon Ian Macfarlane to the Melbourne manufacturing site of GMiA member, Hospira.

The Minister’s visit recognises the healthy economic contribution made by generic manufacturers to Australia’s economy, the ability of medicine manufacturing to support jobs, and the savings the industry delivers to the Pharmaceutical Benefits Scheme.

“Generic manufacturers run world class, high end manufacturing facilities and employ more than 2,500 Australians. We provide high quality medicines to the public and the healthcare system for a fraction of the price. As well as supplying Australia, we also export more than $400M of these medicines annually. Australia should be proud of the contribution the industry makes to both Australia, and the world’s healthcare,” said GMiA Chair, Mark Crotty.

The visit comes at a time when the generic medicines industry is under threat. Recent pricing reforms have cut medicine prices to unsustainable levels that place local manufacturing at risk. Manufacturing policies must recognise the benefit of generic medicine manufacturing to Australia and support its growth and global competitiveness.

The industry is calling on the Minister to convene a Medicine Manufacturing Taskforce, bringing together medicine manufacturers and the Departments of Industry, Health and Trade, with the purpose of identifying opportunities and addressing barriers to medicines manufacturing in Australia. Collectively, this taskforce will explore ways to:
• Cement Australia’s regional reputation for the production of high quality medicines;
• Increase Australia’s medicine export capacity;
• Encourage global investment in Australian medicine manufacturing;
• Commercialise Australian medical and biotechnology R&D;
• Increase the number of highly skilled manufacturing jobs;
• Give Australia the ability to respond in times of pandemic or medicines emergency; and
• Ensure the ongoing surety of supply of medicines for all Australians.
“We are not asking for a handout – just a fair go to keep medicine manufacturing viable to secure Australia’s medicine supply and ensure Australia reaps the benefits of this vital industry.”

– ENDS –