The European Medicines Agency (EMA) is accelerating the development of guidelines to simplify biosimilar development. This policy aims to streamline the approval process by reducing the scope of clinical trial data required. Once established, these guidelines are expected to positively impact Samsung Bioepis and Celltrion, which have been making waves in the European biopharmaceutical market.
Draft Guidelines Prepared; Final Version Expected to Apply in 2026
Today, according to the Korean Biotechnology Industry Organization’s Bioeconomy Research Center, the EMA has drafted guidelines to simplify procedures by reducing clinical data necessary for biosimilar development and regulatory approval.
Previously, biosimilar development required 7-10 years, along with costs for purchasing original drugs for comparative evaluations and recruiting numerous patients.
Through these simplified biosimilar development guidelines, the EMA plans to promote drug development while maintaining EU safety standards.
These guidelines are being created to enhance EU patients’ access to biosimilars while cementing Europe’s position as an optimal location for biosimilar drug development.
The guidelines state that data on structural and functional comparability, efficacy, and pharmacokinetics should suffice to demonstrate similarity to the original drug.
The EMA is currently gathering industry feedback on the guidelines. The final version is expected to take effect in 2026.
According to market research firm, Research and Markets, the European biosimilar market is projected to grow from $10.34 billion in 2022 to $53.22 billion by 2032.
A representative from the Bioeconomy Research Center stated that Europe is set to lose patent rights on 69 medications by 2030. If these guidelines are implemented, it could create greater opportunities for biosimilar companies.
Samsung Bioepis and Celltrion Accelerate European Biosimilar Market Strategy
Leading Korean biopharmaceutical companies Samsung Bioepis and Celltrion are ramping up their efforts in the European biosimilar market. They aim to solidify their existing market share while driving growth with new products.
Samsung Bioepis’ flagship product, Benepali (etanercept), was the first biosimilar the company introduced to the European market and currently leads in market share for etanercept biosimilars. Another autoimmune treatment, Pyzchiva (ustekinumab), has captured a 43% market share in the biosimilar market for Stelara, ranking first.
Celltrion’s key products maintain consistently high market shares globally.
According to pharmaceutical market research firm IQVIA, Remsima IV (infliximab, intravenous formulation) held a 62% market share in Europe as of the third quarter of last year.
When combining figures for Remsima SC (infliximab, subcutaneous formulation), the company boasts dominant shares in major European countries: 89% in the UK, 80% in France, 76% in Spain, and 74% in Germany. In these countries, Remsima SC alone accounts for a 25% market share.
The autoimmune treatment Yuflyma (adalimumab) holds a 16% market share in Europe, with particularly strong showings in Italy (43%), Finland (35%), and Norway (35%). Vegzelma has rapidly grown based on cost competitiveness, achieving the top market share in Europe.
Samsung Bioepis and Celltrion plan to cement their positions as biosimilar leaders in Europe through new product development. They are conducting global clinical trials for biosimilar approval of Keytruda (pembrolizumab), the world’s top-selling drug.
An industry insider noted that unlike the U.S., Europe primarily purchases medications through a bidding process. Given that Korean biosimilars offer high quality and competitive pricing, they are expected to continue performing strongly in Europe.