amp biosimilars successfully out-licenses first biosimilar

amp biosimilars has announced its first successful out-licensing of biosimilar ABY-018, a humanised monoclonal antibody. At present, there are four biosimilars in the ampb product pipeline.

amp biosimilars licensed the biosimilar to a leading mid-sized Chinese pharmaceutical corporation, with a portfolio of more than 50 pharmaceutical products, a GMP-certified production capacity of two billion tablets and one billion capsules per year as well as a national sales network that puts it in an excellent position to pursue commercialisation in China.

The partner will assume all financing for the development and market approval processes starting from Clinical Phase I through to production and marketing of the biosimilar in China. The partner will have the right to unlimited marketing in China and shall pay a percentage of the proceeds to amp biosimilars (royalties). amp biosimilars retains the global rights outside of China. This arrangement allows amp biosimilars to conclude additional out-licensing agreements for the biosimilar, for example in the US, Europe and other Asian countries, or to develop the relevant markets independently and thus generate greater potential revenues. By way of reciprocation, ampb will pay the Chinese partner royalties in the same amount.

"Our team is very happy with this outcome. We have just cleared a decisive hurdle, validating the strength of our business model," said Dr. Marc W. Hentz, chief executive officer of amp biosimilars. "By out-licensing to China, we are not only tapping into the potential represented by this rapidly expanding market, but also have the opportunity of forming partnerships with companies in other markets outside of China. This represents a great step forward, with others soon to follow."

This out-licensing of its first biosimilar also marks amp biosimilar's successful market launch in China. In the course of this, the company benefits from the intensive work and the extensive network that was set up in recent years. The Chinese pharmaceutical market is currently the second largest in the world and has been growing in the past by up to 25 per cent per year. By 2020 the pharmaceutical market is expected to have a volume of 1 trillion US dollars. The Chinese biosimilar market may actually be the largest in the world by 2017, surpassing Europe.