Biosimilars specialist AMP has out-licensed the first candidate biosimilar from its product pipeline, ABY-018, a humanized monoclonal antibody. Although not mentioning names, AMP reported that it had licensed the biosimilar to a leading mid-sized Chinese pharmaceutical corporation, which would finance the development and marketing approval, starting from phase I clinical trials through to production and marketing of the biosimilar in China.

AMP will receive royalties for sales in China and will retain the global rights outside of China. The deal allows AMP to conclude additional out-licensing agreements for ABY-018, for example, in the US, Europe and other Asian countries, or to develop the relevant markets independently. AMP will pay the Chinese partner royalties for sales outside China in the same amount.

Meanwhile, Formycon has out-licensed its second candidate biosimilar FYB203 to German investment firm Santo Holding, who will take over responsibility and the cost of the entire development, manufacture and marketing of the product. In return, Santo Holding obtains the exclusive worldwide marketing rights to FYB203. Pharmaceutical product development to approval will be carried out by Formycon, while clinical development will be carried out by German generics maker Bioeq.

Formycon received an upfront payment of around Euros 5 million and will receive additional milestone payments, as well as royalty payments on sales. The company currently has three biosimilar products under development, marketing of which is expected to begin in the US and EU from 2020 onwards once the patents on the originator products expire. The first candidate biosimilar (FYB201) was licensed out to Santo Holding in December 2013. The pivotal phase III clinical trial for FYB201 is expected to start in Q3 2015.

The company plans to develop its third candidate biosimilar (FYB202), which is currently at the preclinical stage, to the end of phase I clinical trials on its own. This product is expected to be out-licensed in 2018.

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