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Exclusive interview: Samsung Bioepis' Sang-Jin Pak on the rise of biosimilars

pharmafile 2019-12-02 20:20:53


With the publication of the FDA Biosimilars Action Plan last year, it is clear that authorities in the US are keen to investigate the potential of biosimilars for their market. Using the action plan as a framework, policymakers can work alongside developers, insurers and experts to ensure that as many patients as possible have access to treatments. It is estimated that the US market could reduce spending on biologics by up to $150 billion by 2026 if biosimilars were widely adopted.

Samsung Bioepis has put process innovation at the center of our biosimilar business. This has led to the development of high-quality biosimilar medicines which we believe will raise standards across the board and build confidence in biosimilars across all stakeholders.

Only with all stakeholders working together can we realise the ambition of the FDA Biosimilars Action Plan. Overall, additional, high-quality treatment options will provide patients with greater access, removing potential barriers for those most in need of life-changing treatments.


Benepali (etanercept), which was our first biosimilar launched in Europe, is currently available in 25 countries in Europe and is the most prescribed etanercept across France, Germany, Italy, Spain, and the United Kingdom combined.

Additionally, Imraldi (adalimumab), which was launched across Europe one year ago, is currently available in 19 countries and is the leading adalimumab biosimilar in Germany and in Europe year to date 2019.

Different disease areas as well as diverse geographies and regulatory environments can lead to varied levels of uptake of biosimilars, as with any treatment, so it would not be possible for us to compare the success of our treatments.


In Europe, the first biosimilar was approved in 2006; in the US, the first biosimilar was not approved by the US FDA until 2015. As such, we should exercise a certain level of patience, as Europe has had a 10-year head start, whereas biosimilars began entering the US market only recently.

Furthermore, when it comes to biosimilars, one size does not fit all. This is why we are working hard to develop a range of biosimilar options which we hope will provide access to innovative medicines for those who need them most.

Nevertheless, we see tremendous potential in the US market, and remain steadfastly committed to engaging stakeholders across the country to educate them on biosimilars.


We welcome competition – it pushes us to be better and work harder for patients and we strive to ensure that the biosimilars developed by Samsung Bioepis are of the highest quality ensuring efficacy and safety for patients whilst maintaining value for healthcare systems.

For this, we have embedded ‘process innovation’, an innovative approach throughout the entire biosimilar development process ranging from cell line development to regulatory registration. By focusing on what we call ‘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.

In addition, supply continuity is important when it comes to providing biosimilar medicines to patients. At Samsung Bioepis, we implement dual sourcing strategy at every crucial stage of manufacturing in order to prevent supply disruption. We also manage manufacturing and storage sites across different geographic regions, which allow us to efficiently manage supply timeline. It will be our agility and cast-iron commitment to quality that allows us to provide biosimilar medicines to patients who need them, in a timely manner.