Archives for June 2018

Canberra, ACT (June 17, 2018)

The Generic and Biosimilar Medicines Association (GBMA) has announced Renée Richardson as the new project manager for its educational arm, GBMA Education.

Ms Richardson is currently based in Sydney and has recently completed her tenure as Change Manager for the natural healthcare company Soho Flordis International (SFI). Originally trained as a pharmacist, Ms Richardson has previously held senior roles in project management at SFI Research, a research and development company within the SFI Group.

GBMA Chair, Sylvain Vigneault, said he was delighted to welcome Ms Richardson, who will begin her journey with GBMA Education during the week ahead. “As a highly accomplished project manager with extensive experience in healthcare program development, Renée is the ideal person to be taking on this role.”

Ms Richardson will be responsible for managing the activities supported by the Biosimilar Education Grant, which was awarded to GBMA Education by the Australian Government in April 2018.

The launch phase of the grant is now underway, having begun with a series of interactive sessions for healthcare professionals at the Australian Pharmacy Professional (APP) Conference and the Royal Australasian College of Physicians (RACP) Congress in May. UK oncologist Dr Paul Cornes, who has significant experience in the use of biosimilar medicines in Europe, met with a wide range of pharmacists and physicians to provide his expertise and hear their perspectives.

According to GBMA Chief Executive Officer, Marnie Peterson, these activities have been an important first step in listening to the views of local healthcare professionals, identifying a clear focus for future educational initiatives, and providing a platform for the discussion of biosimilar medicines in Australia. She cited surveys conducted with delegates attending the APP2018 and RACP Congress. “While the cohort was limited to conference attendees, the survey revealed that 51% of surveyed retail pharmacists were confident in dispensing biosimilar medicines, while only 20% of surveyed physicians said they were confident in prescribing biosimilar medicines.¹

“That said, the survey also showed that the majority of these healthcare professionals do understand the vital role that biosimilar medicines can play in supporting the sustainability of the Australian healthcare system ­ – even if they don’t yet have personal experience with these medicines,” she said.

Ms Peterson added that there is understandable caution about the implications of biosimilar medicine use in clinical practice, particularly around issues such as multiple switching and tracking and tracing: “So the next step for us, together with key industry stakeholders, is to work toward education that meets the needs of healthcare professionals, and their patients, to support confidence in the use of, and to drive uptake of biosimilar medicines in Australia. By strengthening the GBMA Education team, Renée will play a critical part in facilitating that education.”

Kobe, Japan (June 7, 2018) The International Generic and Biosimilar Medicines Association (IGBA) very much welcomes today’s decision of the ICH General Assembly to elect the IGBA as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

After joining the ICH as a full member of the General Assembly in June 2016, the membership in the Management Committee (MC) is an important next step in the IGBA-ICH relationship. As of June 2018, the IGBA will be represented in the ICH Management Committee by Nick Cappuccino and Beata Stepniewska, current IGBA representatives to the ICH General Assembly.

“To be elected to the ICH Management Committee is a historical moment for our industry, and a great next milestone for the generic & biosimilar industries’ engagement in the international harmonization process”, commented Nick Cappuccino, the Chair of the IGBA Science Committee. We strongly believe, having contributed to the ICH work as an interested party during the last 20 years, that we can now open a new chapter of engaging even more fully in the ICH activities of developing the international standards applied to the pharmaceutical industry, including generic and biosimilar manufacturers”.

“The IGBA is very much looking forward to taking a leadership role in the ICH, and continuing our active engagement in various Experts Working groups through the representation of our members across the five continents”, said Beata Stepniewska, the IGBA representative to the ICH General Assembly. The positive decision of the ICH to elect the IGBA as a Management Committee Member reflects the recognition of values and expertise which the generic and biosimilar pharmaceutical industries can continue to bring to the scientific discussion at the ICH. “

As generic and biosimilar medicines industries are global industries, IGBA is well positioned to continue contributing to the harmonization of the scientific and regulatory standards led by the ICH. Deeper integration and involvement of the IGBA in the ICH Management body will clearly contribute to development and promotion of the ICH regulatory standards among the IGBA membership. This will indeed benefit patients worldwide, providing access to high quality, safe and efficacious generic and biosimilar medicines.

View the media release here.