Samsung Bioepis will launch a collaborative program to help promising biotech startups with overseas clinical trials and product commercialization. The company’s move will provide a big boost to domestic bio startups, which have been hesitant about overseas clinical trials due to high costs.
Industry sources reported on September 6 that Samsung Bioepis set up an open innovation strategy for win-win cooperation with Korean bio startups. It has already started to look for candidate companies.
Samsung Bioepis plans to provide support for companies that are in the clinical trial stage of new drug development after completing the pre-clinical phase (animal testing). It is planning to carry out the remaining phases, including clinical trials, approval and marketing, on behalf of its partner startups.
The cost of going through clinical trials from phase one to phase three in major countries such as the United States and Europe is around 700 billion to 800 billion won (US$583 million to US$666 million). Samsung Bioepis plans to bear the costs incurred since the contract date and recoup its investment after a successful commercialization of a drug by receiving a certain percentage of the sales revenue.
"The purpose of this collaborative program is to support domestic and overseas bio startups and revitalize the industrial ecosystem," said an official from Samsung Bioepis. "We think that it is both a business for profits and a business for social contribution."
It is not easy for bio ventures to directly conduct global clinical trials. It involves an astronomical amount of investment. Furthermore, startups need to know the local circumstances and clinical operation know-how. They also need to have a strong network with the local medical community.
For these reasons, many domestic bio venture companies have difficulties carrying out global clinical trials, even if they have highly potential candidate materials in their pipelines, and in many cases, simply export their skills to multinational pharmaceutical companies. Even after entering clinical phase one, the probability of successful commercialization is only around 10%.
Samsung Bioepis has accumulated experience and know-how by developing five biosimilars since its establishment in 2012. In this process, it has undertaken hundreds of global clinical trials. Thanks to the constant recruiting of clinical experts, it has been conducting clinical trials without assistance from a foreign contract research organization (CRO) since a few years ago.
"This collaboration program will increase the probability of clinical success of bio startups and lower the development risk," said an industry official. "We expect domestic bio startups to branch out overseas more actively."