In 2015, when biosimilars were still new and not widely understood, Samsung Bioepis took its first step into Europe. That step helped open new possibilities in healthcare systems and patient access, which we continue to build on today.

To celebrate a decade of our first biosimilar’s presence in Europe, Namhun Lee, VP of Manufacturing Operations and Business Strategy, reflects on his role in this major milestone. He shares the challenges the company faced and the transformation that followed.

Our First Challenge, Our Purpose

At the time, I was overseeing Supply Chain Management (SCM) operations, working to bring our first biosimilar to the European market on schedule.

It was a demanding period. We had managers from different teams meeting and checking in on progress almost daily. Back then, our meeting room was even used as a temporary coordination space to support final-stage preparations.

Since this was our first commercialized product, we had to navigate much of the process ourselves. I recall setting up a production line at our partner’s overseas facility as one of the major hurdles, on top of the day-to-day operational issues we were trying to solve. There were weeks when it felt like all I could do was focus on getting through the next few days. Still, what kept us grounded was why we were doing it in the first place:

To supply high-quality biopharmaceutical medicines at more reasonable prices to expand patient access.

Biosimilars had very little presence in the market at the time, so there wasn’t much to reference or rely on. In a way, we were figuring things out as we went.

It didn’t really feel like we were taking a risk just to try something new. We believed this was going to matter, even if it took time. And having partners we could work through challenges with made a real difference. That’s what kept us moving forward when the path forward wasn’t fully mapped out.

Exceeding Expectations and Moving as One

When our first biosimilar entered the European market, the response was stronger than we had initially expected. Demand picked up quickly, and our immediate concern was whether we could keep up. From that point on, stabilizing supply became our top priority.

We stayed in close contact with our global manufacturing partners to secure additional manufacturing capacity. At the same time, development, regulatory and quality teams had to move quickly to support production expansion and manage relevant approvals.

I still remember how closely everyone worked together to move the Process Performance Qualification (PPQ) variation approval forward. We were able to complete all the necessary approvals in a short period of time.

Looking back, it wasn’t just a response to what was happening at the time. It was a moment that showed how the whole organization could come together and move in the same direction.

The Samsung Bioepis DNA: Forged by Experience

The success of our first biosimilar shaped a lot of how we work today at Samsung Bioepis, and continues to do so. It was during that time that we started using a Process Map-based approach to problem-solving. We broke things down step by step, defining the tasks clearly and looking at inputs, outputs, and what we could actually control at each stage.

In our first global project, teams across SCM, Finance, External Manufacturing Management (EM) and Quality Assurance (QA) worked closely to identify and organize dozens of tasks and clarify roles along the way. That way of working has stayed with us, and is now a natural part of how teams collaborate and execute at Samsung Bioepis.

It took a lot of coordination and problem-solving to bring our first biosimilar to the European market.

The sense of accomplishment I felt then is something I still carry with me.
It gave me confidence to take on new challenges.

The Start of One Thing Changed Everything, and the Next 10 Years

The success of our first biosimilar was not a one-off achievement. It led to further pipeline expansions and new projects, opening up new opportunities.

To those with limited access to healthcare, Samsung Bioepis’ biosimilars help more patients receive treatment. They allow earlier access in certain disease areas and potentially slow the progression of these diseases. For us, that impact is what matters most. And it is only possible because of a consistent focus on quality and trust.

Rather than focusing on what we have already achieved, we are looking ahead to what comes next.

The next 10 years will bring a lot of change to the biosimilar industry. With AI-based R&D, new therapies and emerging technologies continuing to develop, we need to stay flexible and keep learning as we go.

As the biotech landscape evolves, Samsung Bioepis is preparing for the long term, so we can become a company with a 100-year history. If the last 10 years were our starting point, the next 10 will be about building on that foundation and continuing to grow.

I often think about the anniversary photos we used to take each year at our old office. You could see the company growing as more people filled the space over time. Though we are now in a different environment with even more colleagues, those memories are still fresh in my mind. Samsung Bioepis has come a long way, and I look forward to continuing this journey with my colleagues.