By Anna Rose Welch, Director, Cell & Gene Collaborative
In February 2017, I found myself in Philadelphia interviewing a VP at Samsung Bioepis about the company’s efforts to establish its process innovation. It was this process that enabled the company to have three biosimilars approved in Europe, two submitted for EMA review and one for FDA review — all in five brief years.
Today the company has seen all of its biosimilars under European review approved, and a majority of them have been launched, including Europe’s first Herceptin biosimilar. In the past year, the company also announced its partnership with Takeda to codevelop novel biologics. So, when I realized Brian Hosung Min, an SVP and head of drug substance at Samsung Bioepis, would be presenting at the World Biosimilars Congress in San Diego in May of this year, I jumped at the opportunity to see how far the company and its process innovation had progressed. Over lunch, Min explained the company’s ongoing efforts to realize a lower cost of goods sold (COGS), speed up production, and manage risk in biosimilar and novel biologics development.