Press release

EuropaBio joins the Alliance for Safe Biologic Medicines

Ensuring that patient safety is at the forefront of the biosimilars policy discussion.

EuropaBio is pleased to announce its membership of the Alliance for Safe Biologic Medicines (ASBM).

The ASBM is an organization composed of diverse healthcare groups and individuals from patients to physicians, and biotechnology companies that develop innovative and biosimilar medicines and other stakeholders who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion in the U.S. and across the globe. 

“EuropaBio member companies are highly committed to working together with biological medicines and biosimilar manufacturers, health care professionals, patient groups and other key stakeholders to ensure patient safety is at the forefront of the biological policy discussion”, commentedEuropaBio Biosimilar topic group leader Stefan Bergunde.“Biological medicines cannot be copied in the same way as small molecule drugs can be, so different considerations must be taken into account in policy decisions. Biosimilars have an important role in offering physicians an additional treatment option to choose from to manage their patients’ health”, Bergunde continued.

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 a member of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics surrounding 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.

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 biological and biosimilar medicines. The development and manufacturing process for all biological medicines and vaccines, including biosimilars, is more complex compared to the process 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 and adapted to all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”


Notes to the editor:

Biosimilars: A biosimilar is a biological medicine which is similar to another biological medicine that has already been authorised for use (the ‘reference medicinal product’). A biosimilar and its reference medicinal product are expected to have the same safety and efficacy profile, and biosimilars are authorised either for all or select indications of the reference medicinal product on a case-by-case basis.

About EuropaBio: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. 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.

About the Alliance for Safe Biologic Medicines: ASBM is the leading voice for patients who would benefit from the introduction of biosimilar medicines both in the U.S. and across the globe.  The mission of the Alliance is to ensure that patient safety remains the cornerstone of efforts to bring biosimilars to patients.  ASBM members come primarily from the patient and physician community and as a result understand the importance of being assured of both the quality of the medicine and the safety of its use.