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2026/05/19 [Re:Access] Newsletter Issue #9 - Biosimilars Are Advancing. Policy Must Keep Pace.

 

Longer lifespans are one of modern medicine’s greatest achievements, but it comes with a cost.

 

Healthcare systems are struggling to manage aging populations while facing the rising costs of modern medicine. To make healthcare truly sustainable, we must find ways to expand access to biologic medicines without draining national budgets.

 

This is why biosimilars are now a central part of the global healthcare conversation. They offer a rare opportunity to improve patient options while keeping costs under control.

 

A Unified Committee for Bio Innovation

 

On April 16, the Republic of Korea launched the National Bio-Innovation Committee. This body unifies the National Bio-Committee and Bio-Health Innovation Committee under a single governance structure to coordinate bio-policies and strengthen policy momentum.

 

During the event, Kyung-Ah Kim, the President and CEO at Samsung Epis Holdings, suggested that part of the solution to today’s healthcare challenges may already exist:

 

“Republic of Korea is rapidly becoming an aging society … how can we secure the financial soundness of our health insurance and provide more treatment options to more patients? I believe one solution that can help solve this is the biosimilar.”

 

Korea is already a key player in the global biosimilar market. The country has built a reputation for advanced manufacturing, and research and development. Yet, as Kim emphasized, even the best products need a supportive environment. For these medicines to reach their full potential, the policy landscape needs to change.

 

Adoption Takes More Than One Policy

 

Over the past decade, biosimilar progress has centered on science and regulation, lowering barriers and expanding treatment options. However, approval alone is not enough, as real impact depends on everyday use. Without the right support systems in place, these treatments risk being overlooked despite their high quality and cost advantages.

 

Many markets are already seeing success through coordinated policy approaches. Kim highlighted this, noting that many countries are “increasing the utilization of biosimilars through various policies, such as providing incentives to educational hospitals or doctors and introducing prescription quotas.”

 

What stands out is not a single policy, but the combination of approaches. Adoption increases when several strategies work together:

●  Education: Patients and healthcare providers are supported with clear information, so they understand that biosimilars are as safe and effective as originators.

●  Incentives: Hospitals keep part of the savings from using biosimilars through “gain-sharing” and reinvest them into their own services.

●  Target and Quota Systems: Governments including the UK and Japan set prescribing targets to encourage use, and some also combine them with quotas, as seen in Germany.

 

 

In contrast, while Korea has established a strong biosimilar foundation, adoption in practice still lags. Measures that support uptake, such as prescribing incentives, targets and education, are not yet widely in place.

 

Recent policy moves suggest this is starting to receive more attention. The launch of the National Bio-Innovation Committee brings more coordination across bio-related policies. Efforts to simplify regulations also point to a growing focus on linking development strength with actual use in the healthcare system.

 

This gap between development and use is one of the key challenges Kim pointed to. And it is not unique to Korea. In many markets, changing regulations, tariffs and inconsistent policies still make long-term investment in biosimilars difficult.

 

The Next Phase of Biosimilars

 

While developing biosimilars and securing approval remains important, the focus is increasingly on how widely they are used in everyday care by doctors and patients.

 

Countries seeing the greatest impact are those that pair strong manufacturing capabilities with clear, consistent policies. This helps drive uptake, expand patient access, and manage healthcare costs.

 

Samsung Bioepis is focused on this next step, contributing to the global conversation to help ensure biosimilars deliver on their promise. The science is ready and more products are becoming available. Now, policy needs to keep pace so more patients can benefit.

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SAMSUNG BIOEPIS

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