PharmaLab Congress 2016
   

Biosimilars - Case Studies and Practical Advice

8 November 2016


Objectives

This conference should give you practical examples and guidance, how to develop biopharmaceutical generics, what are the common pitfalls and an inside view in possible approaches for their solution. Speakers from developing and manufacturing companies, supporting laboratories and experienced consultants will share their knowledge with you and discuss the current developments.

Background

With the increasing number of biopharmaceutical products with an ending patent protection, more and more companies may choose to develop a biological medicinal product claimed to be “similar” to a reference medicinal product, which has been granted a marketing authorisation . The Authorities expected in such a case, the demonstration of the similar nature of the two biological medicinal products by the submitting company. Comparability studies are needed to generate evidence substantiating the similar nature, in terms of quality, safety and efficacy, of the similar biological medicinal product and the chosen authorised reference medicinal product.

Therefor, the European Authorities as well as the US FDA published several guidelines, e.g. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1, October 2014) or Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (FDA, April 2015). The demonstration of the similarity of biological products appears much more difficult than the development of chemical generics, related to the higher complexity and variability of biological systems.

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