GoINPHARMA™ meets Brian Min, Senior Vice President and Head of Drug Substance, Samsung Bioepis

 

Brian Min SVP Samsung Bioepis

Brian Hosung Min is currently the Vice President of Process Team at Samsung Bioepis Co., Ltd.   He is in charge of process development and manufacturing of all biosimilars at Samsung. His expertise includes biologics development from discovery to manufacturing as well as strategic planning and project management. Before moving to this position, he was the Head of Antibody Engineering at Samsung Advanced Institute of Technology, in charge of developing novel antibody-based therapeutic platform and antibody biosimilar development. Before joining Samsung in 2008, Dr. Min was Principal Scientist at Amgen for over 10 years in charge of biologics discovery and optimization, developing multiple protein therapeutics that are currently in clinical trials or in the market. He holds a B.A. from University of California, Berkeley and a Ph.D. from University of California, Los Angeles

 

Goinpharma: Let’s start talking about what Samsung Bioepis is today after Biogen joined the group and how the company has developed in recent years?

 Dr. Brian Hosung Min: Since we were established six years ago, we have been dedicated to growing our company in a number of areas, ranging from preclinical and clinical development to regulatory and medical affairs. Currently, we have over 800 employees in two campuses located in Incheon and Suwon. Both cities are located within an hour from Seoul, Korea’s capital.

Being based in Korea has allowed us to tap into the country’s strong natural science foundation, giving us access to a large and highly qualified talent pool of young and energetic university graduates from throughout the country.

Based on our scientific expertise and commitment to quality, in just six years, we have been fortunate enough to launch four biosimilars in Europe. So far, our biosimilars have treated over 100,000 patients across Europe with approximately 6 million doses administered. We are very proud of this milestone, as it shows that we are already making a positive difference for patients and healthcare systems in various countries.

We have strong manufacturing partnerships with Biogen and other top contract manufacturing organizations (CMO’s), which allow us to produce high-quality medicines that are consistently and reliably supplied to patients across the world. Together, these advances have put us at the forefront of the the race to develop a thriving global biosimilar market, and we expect this momentum to continue.

Goinpharma: Biosimilars are definitely Samsung Bioepis’ therapeutic sector par excellence, a sector which is fast growing and whose market will reach $30bn in sales by 2021. What do you think are the reasons of biosimilars’ success?

Dr. Brian Hosung Min: Biosimilar uptake in Europe can be impacted by a number of issues. Foremost among them is the knowledge of biosimilars among key stakeholders, including patients, physicians, and payers. Surveys over the years have shown that sound science-based information has been improving the perception of biosimilars across Europe. This may be largely attributed to physicians and other healthcare providers having greater familiarity with the science behind biosimilars, as well as the positive experiences they’ve had in prescribing and treating patients with these high-quality medicines.  A growing wealth of real-world data has also played an important role, as they have shown how biosimilars have fared outside of the clinic.

Due to these reasons, we believe the environment for biosimilar uptake in Europe has significantly improved and will only get better over the coming years.

GoINPHARMA: Can you tell us more about the peculiarities of the process of developing and producing biosimilars developed by Samsung Bioepis and how it differs from its competitors?

Dr. Brian Hosung Min: We entered the biopharmaceutical industry with a strong determination to transform and enhance the way therapies are brought to patients from conception and development through regulatory approval. This means replacing legacy processes with new and innovative ones, as evidenced in what we’ve done so far with biosimilars. Internally, we call this “process innovation.”

Our process innovation platform has three components to be successful. One is our highly qualified and passionate colleagues. Two is the fact that we continuously bring in and implement state-of-art technologies to develop our products. And, last but not least is our system that includes concepts such as Quality by Design (QbD), Failure Mode Effects Analysis (FMEA), and Lessons Learned. Some of the concepts we use come from outside of the pharmaceutical industry, as our goal is to implement the best possible solutions to the challenges involved in developing biosimilars.

We have embedded this innovative approach throughout the entire biosimilar development process, ranging from cell line development to regulatory registration.

By focusing on process innovation, we have been able to provide high-quality medicines in a shorter period of time at a lower cost, without making any compromises to requisite safety or quality.

GoINPHARMA: Your group’s pipeline is probably the richest of all companies in the biosimilars sector, which are your most promising candidates and what are your expectations in terms of market shares that these candidates will gain once they are offered the market?

 Dr. Brian Hosung Min: We have multiple biosimilar candidates in our pipeline. Four of them have been approved in Europe, while two remain in late-stage development and one in early-stage development. We chose these candidates, because we wanted to positively impact the lives of as many as patients as we could. And, currently in Europe, over 100,000 patients are being treated with our biosimilars. With the recent addition of ONTRUZANT, which treats certain types of breast cancer, and IMRALDI, which treats a range of autoimmune conditions, we hope to see more patients benefit from greater choice of high-quality medicines across Europe.

GoINPHARMA: Lastly, how the launch of IMRALDI is progressing and what are Samsung Bioepis’ future steps in terms of new production capacity and entry into new therapeutic areas?

Dr. Brian Hosung Min: Currently, we have access to 360 kL of manufacturing capacity at highly reputed CMOs, and have not had any issues meeting demand. As for our entry into novel biologics development, entering this space has been a goal since day one, and at this stage of our company’s development, we believe this is the next logical step. That said, I would like to clarify that we are not looking to make a sudden leap. Rather, we’re taking a measured, step-by-step approach to gradually develop and integrate a complete set of capabilities at Samsung Bioepis, so that in 10 years’ time, we will have amassed end-to-end capabilities that will allow us to undertake all phases of novel biologics development.

The first step in this approach is the strategic collaboration agreement that we have signed with Takeda. Under the terms of the agreement, the two companies will jointly fund the development of multiple novel biologic therapies in unmet disease areas. The risk-sharing partnership brings together Samsung Bioepis’ agile biologics development platform with Takeda’s best-in-class experts in drug development to co-fund and collaboratively develop innovative therapies representing meaningful value to patients who need them.

Going forward, we will continue to look for additional co-development opportunities with multinational pharmaceutical and biotech companies. Our model is to bring in assets from these companies with full development rights, as well as a share of future sales upon successful registration and commercialization of the therapy.

For further information

Andrew Ward

FTI Consulting

+44 (0)20 3727 1179 (T)

andrew.ward@fticonsulting.com