WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership.
EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises across Europe. Its members are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes, and have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.
“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines. “We are pleased to have such an authoritative international partner who brings an experience with biosimilars that does not currently exist in the U.S. We will lean heavily on EuropaBio and its members to better understand the approach taken in the E.U. that has led to the successful introduction of biosimilars.”
In April 2013, the Process on Corporate Responsibility in the field of Pharmaceuticals, spearheaded by Commission Vice-President Antonio Tajani, published its long-awaited report on biosimilars. As members of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure informed and adequate use of these medicines.
The Alliance for Safe Biologic Medicines has had an established International Advisory Board for the purpose of providing ASBM’s Chairman, member organizations, and the general public guidance and expertise as the FDA moves forward to implement a pathway for biosimilar medications. However, the partnership with EuropaBio furthers that mission by serving as an important resource as they evaluate the future of biologics and biosimilars in the United States, Canada, and the EU.
“Countries across the globe have gathered much data which can, at a minimum, help inform our own policy makers,” Executive Director of ASBM, Michael Reilly, stated. “The ASBM will take advantage of the opportunity to learn from their experiences, both positive and negative.”
Miriam Gargesi, Director of Healthcare at EuropaBio added: “We look forward to working with ASBM to continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products. It is therefore necessary that a robust regulatory system and adequate label transparency are in place for all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”
About the Alliance for Safe Biologic Medicines:
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
For more information, please contact:
Alliance for Safe Biologic Medicines
Communications Manager, EuropaBio
Phone: +32 2 739 1173
GSM: +32 (0) 478 680 301