WHA 67 agenda item 15.6 Regulatory system strengthening (resolution EB134.R19)
Delivered by Janis Bernat, Associate Director, Biotherapeutics and Scientific Affairs
Check against delivery
15.6 Regulatory system strengthening (resolution EB134.R19) Access to biotherapeutic products and ensuring quality, safety and efficacy
Thank you for the opportunity to provide input to this important discussion. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) represents the leading research-based pharmaceutical companies as well as national industry associations across the world.
Science-based regulatory standards for medicines are essential. Given the complex nature of biotherapeutic medicines and the resulting challenges in characterization, specialized testing is required to ensure their safety and efficacy. As a result, similar biotherapeutic products (or biosimilars) should be regulated via pathways that are distinct from those traditionally applied to generic medicines.
In 2009 WHO established guidelines on evaluation of similar biotherapeutic products followed in 2013 with guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology. Uniform regulatory requirements following World Health Organization (WHO) principles and guidance for all manufacturers should be developed to ensure that all biotherapeutic medicines are safe and efficacious.
Madam/Mr Chair, biotherapeutic medicines are an important and integral component of modern medicine that targets many chronic and acute disease areas with highly-specific treatments. These complex medicines allow both the individual patient, through improved quality of life, and ultimately, society to benefit from their use.
Thank you.
About IFPMA
IFPMA represents the innovative pharmaceutical industry at the international level, engaging in official relations with the United Nations and multilateral organizations. Our vision is to ensure that scientific progress translates into the next generation of medicines and vaccines that deliver a healthier future for people everywhere.
ifpma.org
To achieve this, we act as a trusted partner, bringing our members' expertise to champion pharmaceutical innovation, drive policy that supports the research, development, and delivery of health technologies, and create sustainable solutions that advance global health.
Related news and resources
Pharmacy-mediated substitution for biosimilars
This position paper from IFPMA addresses substitution relating to biosimilars and their reference products at the retail pharmacy level. While this practice has been in place in many countries for generics, for biosimilars, the practice is only emerging.
Read more
Synthetic follow-on products that reference biologically produced medicines
The focus of this paper is follow-on versions of smaller protein products developed to be marketed following expiry of patent and data protection of the reference product. They are synthetically produced while the reference product is manufactured recombinantly.
Read more