This week, the International Generic and Biosimilar Medicines Association (IGBA) was elected as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
This week, the International Generic and Biosimilar Medicines Association (IGBA) was elected as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The ICH works to achieve “greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner,” according to their mission statement.
The Management Committee of the ICH is a distinguished group of ICH members that help to oversee the operational aspects of ICH on behalf of all members, including administrative and financial matters, in addition to the oversight of working groups.
IGBA joined the ICH in June 2016 as a General Assembly member. With its newly elected role, the IGBA will be represented at Management Committee meetings by 2 current IGBA representatives.
“To join the ICH as Management Committee’s Member is a historical moment for our industry and next milestone for the generic and biosimilar industries’ engagement in the international harmonization process,” said Nick Cappuccino, chair of the IGBA science committee and one of IGBA’s representatives to the ICH General Assembly, in a statement.
The IGBA believes that, by being more deeply involved with the ICH Management Body, it can drive deeper integration of ICH regulatory standards among its own membership. This working partnership will in turn, it says, benefit patients worldwide and provide them with access to high quality, safe, and effective generic and biosimilar medicines.
“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 bring to the scientific discussion at the ICH,” said Beata Stepniewska, the second IGBA representative to the ICH General Assembly.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.