The nation of South Korea has overtaken many of its regional counterparts to boast a highly impressive biosimilars pipeline. Here, key stakeholders in Korean biologics and biosimilars explain how.
Once we chose to specialise in biosimilars, there was no room to survive if we failed with the few projects we had
As Tae-Han Kim, president and CEO of Samsung Biologics, avows, “Samsung Bioepis has the largest number of approved products by the FDA and EMA, followed in second place by Celltrion.” Not only in terms of approvals is Korea on top either, in terms of company rankings by biosimilar revenue, Celltrion is leading the way and Samsung Bioepis is second.
“It is sometimes thought to be very difficult to discover new molecules or develop biosimilars. Today this is no longer the case” declares Samsung Biologics’ Kim. “There is a new generation of scientists involved in novel biologics who have gained knowledge and skills. Accordingly, modern biosimilar production is actually relatively straightforward in terms of finding and developing new products,” he adds.
Explaining how Korea specifically managed to rise to such a stature in the world of biologics, TH Kim recalls, “The western companies began five or six years earlier than the Korean companies. However, we have caught up and dramatically cut our approval times. People often ask me how this was possible. The answer is that we went “all in” – complete dedication to the market. Once we chose to specialise in biosimilars, there was no room to survive if we failed with the few projects we had”.
One of the main issues facing developers of biosimilars is the bottleneck surrounding global approvals. “In my opinion, many companies either fail to gain approvals, or the process is delayed because of their inadequate manufacturing facilities” hypothesizes TH Kim. He continues, “Although over 100 companies have products that have received approval by either the EMA or the FDA, most do not possess the capacity for production and have failed to improve their facilities and operation technologies in line with their R&D advancements”.
Soon Jae Park, CEO of Alteogen, a biotech developing bio-better products – derivative variants of the original biologic molecule which show improvement in one or more attributes over the original – concurs, “we have to understand that the drugs produced, although being called biosimilars, are essentially new biological entities. This means that there is no standard program for drug manufacturing, so clearly production capabilities affect the progress of the product”.
While global players like Samsung Biologics have overcome these challenges, smaller biotech companies must take a shrewder approach to making it in the biologics world – “Alteogen needs to be smart in order to survive,” asserts Soon Jae Park. “Consequently, Alteogen is looking for partners that have the manufacturing capabilities and are able to help us in the further steps of the product development” he adds.
For Korea to truly entrench itself as a biologics leader, the challenge is not only to innovate within manufacturing, but to develop the most innovative products. Despite recent manufacturing successes, some have voiced the concern that fast followers will emerge with which Korea cannot compete on costs. “I do not think that biosimilars will be very attractive for Korean companies in ten years. Costs in Korea will further increase and developing countries will catch up. Even today, countries like China and India can produce biosimilars, obviously at a lower price,” declares Soon Jae Park.
The next stage for the industry is to leverage its strengths in biosimilars as a launchpad for new biologics and, like Alteogen, biobetters. “Korean companies will need capabilities to develop their own biological drugs based on new chemical entities in order to compete,” proposes Park.
“To illustrate this point with an example, Alteogen has developed NexP™ Fusion Technology, a next-generation long-acting bio-bettter technology. This shows excellent long-acting properties without causing any loss of activity as medicines, so they can stay longer in the body,” reveals Park. Making this innovation the norm will help entrench Korea as the leading player in the biologics game.