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International Federation of Pharmaceutical Manufacturers & Associations

Pre- International Conference of Drug Regulatory Authorities (ICDRA)

As government officials and drug regulatory authorities meet in Rio de Janeiro on the 26th-29th August for the 16th International Conference of Drug Regulatory Authorities (ICDRA), a pre-conference entitled “Ensuring Quality and Safety of Biosimilars for Patients Worldwide” will take place 24-25 August 2014. More than 400 experts from drug regulators, academia, non-governmental organizations and international organizations through to the pharmaceutical industry will be in attendance. Experts from IFPMA’s Biotherapeutics Group will be actively involved as speakers on important issues including regulatory challenges; the way forward for different types of biotherapeutic products; how to accelerate access; ensuring safety through pharmacovigilance; and whether similar biotherapeutic products should have or share the same International Non-Proprietary Name (INN) as originator biotherapeutics. 

Biotherapeutic medicines in a few words

Biotherapeutics are the new generation of medical treatment that is making a genuine difference in people’s lives who are suffering from cancer, diabetes, rheumatoid arthritis, multiple sclerosis, hepatitis C, and chronic renal failure – as well as less common ones such as hemophilia, Fabry’s disease, growth deficiency and Crohn’s disease. 

The current challenges in the field of biotherapeutic medicines

Access to biotherapeutic products, including biosimilars, and ensuring their quality, safety and efficacy will be important challenges in the future. Science-based regulatory standards for medicines, in alignment with World Health Organization (WHO) guidance, are essential to ensure patient safety, and implementation of these standards at the national level will be critical moving forward. 

The current situation in Latin American countries regarding the production of biotherapeutic medicines, including biosimilars

Latin America is a region full of opportunities when it comes to biotherapeutic medicines, including biosimilars. A key challenge for the region is that there are some countries where biotherapeutic products have been licensed under regulatory pathways that do not have appropriate standards for the approval of biotherapeutics medicines. Biotherapeutic medicines are even more complex than traditional, chemically-synthesized medicines and therefore require separate processes for approval. 

Strengthening pharmacovigilance for biotherapeutics medicines is key

Pharmacovigilance systems are widely recognized as important tools in the regulatory process for medicines as well as protecting public health and providing an integral component of patient healthcare. The WHO describes a national pharmacovigilance system “as an obligatory investment in the future public health of the territory”. Experts at Pre-ICDRA will discuss the importance of pharmacovigilance and risk management processes for patients’ safety.

To find out more about biotherapeutics, we encourage our readers to consult the resources attached to this link. For media queries, contact: s.kaenzig(at)