Big strides in biosimilar mAbs
Polish antibody development and manufacturing specialist Mabion S.A. more than tripled its revenues in 2011 (€2.5m) compared to 2010 (€0.74m). The increase in turnover mainly resulted from stronger client demand for R&D services when applying Mabion’s technologies for manufacturing biosimilar antibody drugs, according to the firm’s CEO Maciej Wieczorek. Mabion currently runs three undisclosed biosimilar monoclonal antibody (mAb) development programmes for clients and four in-house programmes. After the Polish biotech received permission to manufacture medicinal products for clinical trials from the country’s main pharmaceutical inspecting body in December, it began preparing for clinical testing of its lead candidate MabionCD20, which has been developed in-house with the help of a €10m EU fund granted through the Polish Agency of Enterprise Development. Mabion and the CRO Kiecana Clinical Research are now preparing a clinical trial that will compare MabionCD20’s pharmacokinetics and pharmacodynamics to Roche’s originator product rituximab. The company hopes to file for EU approval for the substance in 2013.
The firm’s second programme MabionHER2, a copycat mAb for treating breast cancer, is still in the analytical method development phase and in vitro testing to confirm biosimilarity. Mabion
EGFR against colorectal, head and neck cancer, and MabionVEGF, a medicine for lung, breast, colorectal and kidney cancer have both entered the stage of cell development, according to Wieczorek.