Masterarbeit

Challenges and Chances of the Development of Biosimilar Monoclonal Antibodies in the EU

Dr. Leonie Hempel (2012)

Summary

Therapeutic monoclonal antibodies (mAbs) are the top sellers among biopharmaceuticals. However, patent protection terms of the first generation of mAbs are soon coming to an end. Due to high revenues, these mAbs are attractive reference products for biosimilars, and several biosimilar monoclonals including rituximab and trastuzumab are already in the pipeline.

The development of biosimilar mAbs is not without risks as mAbs are highly complex proteins subject to post-translational modifications. Due to their high level of microheterogeneity, biosimilar mAbs are more complex than any other biosimilar approved to date. This complexity poses several challenges to manufacturers and regulators in defining the requirements for comparability.

In this work, the current regulatory requirements for demonstration of biosimilarity of mAbs are reviewed and discussed. In addition, the chances for market penetration and revenues for mAbs were assessed. Lack of interchangeability with originator products as well as the lack of automatic substitution will hamper market penetration and lower revenues. Furthermore, biosimilars will have to compete with biobetters, which are already in the pipeline as well. In light of these risks, pharmaceutical companies may be well advised to largely focus on the development of biobetters rather than biosimilars.

Pages: 52