Samsung Bioepis Files South Korea's First Approval for Biosimilar of Merck's $32.4 Billion Cancer Drug Keytruda — BigGo Finance
Samsung Bioepis filed South Korea’s marketing authorization application for SB27, its pembrolizumab biosimilar to Merck’s Keytruda, on Aug 7, according to the company. It is the first Keytruda biosimilar application in South Korea. SB27 is supported by Phase 1 (163 patients) and Phase 3 (555) trials showing equivalence. Keytruda’s South Korea substance patent expires in 2028.
How this was made
The 30-second read
Why it matters
For Samsung Bioepis, the filing is a concrete regulatory milestone that can improve probability-weighted future oncology revenue. For Merck, it increases competitive risk to Keytruda in South Korea, but the domestic substance patent expiry in 2028 suggests limited immediate financial impact.
Market read
A first-in-South-Korea Keytruda biosimilar marketing authorization filing is a tangible step toward future competition, with patent expiry likely delaying commercialization.
What to watch
Commercialization strategy (partnering vs direct sales vs private label) and the eventual review outcome could materially change the competitive impact versus what the filing alone suggests.
Background
Samsung Bioepis submitted South Korea’s first Keytruda biosimilar marketing authorization application for SB27 (pembrolizumab), citing global clinical trial equivalence and a streamlined review pathway.
Ticker impact
The article frames Keytruda as Merck’s blockbuster and notes SB27 is a biosimilar candidate targeting Keytruda indications in South Korea.
Limited immediate impact; watch for incremental competitive risk premium as more biosimilar milestones emerge.
The text highlights patent expiry in 2028 domestically and sequential expiries globally, implying competition is a medium-term threat rather than an immediate earnings hit.
Market effects
Adds to the biosimilar competitive landscape for PD-1 immunotherapy in oncology, reinforcing that Keytruda biosimilars are moving through major-market regulatory pathways.
South Korea becomes a nearer-term battleground as SB27 enters the approval process under streamlined biosimilar review rules.
Highlights the global patent-expiry timeline (US 2029, EU 2031), which can shift expectations for biosimilar market entry sequencing across regions.
Counterpoint
A marketing authorization filing does not guarantee approval, and patent expiry timing (2028 in South Korea) may cap near-term revenue implications for Merck.
Key entities
- companySamsung Bioepis
Filed South Korea marketing authorization application for SB27, a Keytruda biosimilar candidate.
- product_candidateSB27
Samsung Bioepis’ pembrolizumab biosimilar candidate targeting Keytruda indications.
- drugKeytruda (pembrolizumab)
Merck’s PD-1 immunotherapy blockbuster with many approved indications and major global sales.
- companyMerck
Originator of Keytruda; faces biosimilar competitive pressure as SB27 advances in South Korea.
- regulatorSouth Korea Ministry of Food and Drug Safety
Receives the marketing authorization application and applies streamlined biosimilar review policy.
