Synthon Successfully Concluded Phase I Clinical Trial for Trastuzumab

Synthon’s first truly biosimilar product now embarking on phase III study

26-Mar-2012 - Netherlands

Synthon announced that it has successfully concluded a phase I clinical trial for trastuzumab, a biosimilar to Herceptin©, for treatment of breast cancer and gastric cancer. The company will now initiate a phase III clinical trial for trastuzumab, bringing an affordable alternative for treatment of breast and gastric cancer closer to the market.

All in vitro and in vivo studies conducted so far showed biosimilar behavior of Synthon’s trastuzumab in comparison with the reference product, Herceptin®. The outcome of the phase I clinical trial confirmed these results, showing bio-equivalence of Synthon’s trastuzumab to Herceptin®.

“Trastuzumab is one of the most advanced biopharmaceutical products of Synthon’s pipeline, and is now ready to go into a confirmatory phase III clinical trial in breast cancer patients,” says Rudy Mareel, CEO Synthon. “Biosimilars are to Synthon a serious stepping stone towards the development of biosuperior and truly innovative biological products. We are very excited about our growing portfolio of new biological antiproliferative agents that is well positioned next to our biosimilars.”

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