Life Science Industry Coalition Position paper

IGBA biosimilar medicines slide decks

The era of biological medicines
Since their first use in the 1980s, biological medicines (including biosimilar medicines) have grown to become an indispensable tool in modern medicine. Worldwide, millions of patients have already benefited from approved biological medicines, but what exactly are they, and how are they produced?


Biological medicines ― the major social and economic challenges
The global spend on pharmaceuticals continues to increase. The use of biological medicines offers new treatment choices to patients, but at a high financial cost. What are the challenges faced by payers and physicians in preserving access to biological medicines within a financially constrained healthcare system?


Biosimilar medicines — rising to the cost challenge
Addressing the rising cost of biological medicines has become a priority for governments and healthcare systems around the globe.
Biosimilar medicines are providing more cost-effective biological treatments, but what are biosimilar medicines, and how do they meet this challenge?


Biosimilar medicines — a commitment to scientific excellence
With biosimilar medicines, patients and healthcare providers benefit from high quality and efficacious therapeutic alternatives.
But how are biosimilar medicines developed, and how is their efficacy and safety ensured?


The benefits of biosimilar medicines
Biosimilar medicines have demonstrated similarity with reference biologicals in terms of structure, function, safety and efficacy, but what are their benefits?


Building on the experience and success of biosimilar medicines
Biosimilar medicines are increasingly becoming an integral part of modern healthcare systems, so what does the future hold?


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How come that biosimilar medicines are still heavily debated today?

What is needed to familiarize oncologists with biosimilar medicines?

What is the role of clinical trials in biosimilar development?

What are the key messages of the ESMO 2017 symposium?

Position Paper: for an ambitious EU industrial strategy

SPC manufacturing waiver

Fighting counterfeit medicines in Europe: the effect on access to medicines

The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional safety features, as well as the repository system that will allow the verification of authenticity of individual packs of medicine, may threaten the availability of medicines.


Maarten Van Baelen, Pieter Dylst, Catarina Lopes Pereira, Johan Verhaeghe, Koen Nauwelaerts, Susie Lyddon

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2017 Market Review – Biosimilar Medicines Markets – Policy Overview