The Global Patent Cliff and K-Bio's Push into the Biosimilar Market
🧬 1 The Patent Cliff and a Massive 600 Trillion Won Market
In the global pharmaceutical market, about 200 exclusivities will expire one after another by 2030, including 70 blockbuster drugs with annual sales of 1 billion dollars (1.4 trillion won) or more
As a result, the revenue that originator drugmakers will lose, that is, the cumulative target market that biosimilar (generic) companies can capture, is expected to reach about 600 trillion won (up to 400 billion dollars)
The fiercest competition is expected in the autoimmune disease treatment market, including Stelara, Dupixent and Xeljanz, with combined global sales of 33 trillion won
Samsung Bioepis (Pyzchiva) and Celltrion (Steqeyma) have already obtained approval for Stelara biosimilars in the United States and Europe and have begun targeting the North American and European markets simultaneously
On top of that, with the traditional drugmaker Dong-A ST (Imuldosa) also receiving U.S. FDA approval, an unusual golden window has opened in which three K-Bio companies go head to head on the global stage
🚀 3 Favorable Winds of Deregulation and Gaps in the European Market
Starting this year, guidelines exempting costly Phase 3 clinical trials for biosimilar development are set to apply in the United States and Europe. This dramatically reduces the development costs and time for latecomers, maximizing profitability
According to the Korea Biomedicine Industry Association, of the 100 biopharmaceuticals that will lose exclusivity in Europe by 2032, a full 79 percent are in a blue ocean with no biosimilars yet in development
🛡️ 4 The Counterattack of Originator Big Pharma: The Evergreening Strategy
The defenses of originator drugmakers trying not to lose the market are also formidable. A typical example is the evergreening strategy of extending patent terms by switching existing intravenous (IV) injections to subcutaneous (SC) formulations or adding new indications
In fact, ahead of the 2028 patent expiry of its immuno-oncology drug Keytruda, Merck (MSD) launched Keytruda Qlex, a subcutaneous injection using technology from Korea's Alteogen, building a strong line of defense that blocks biosimilar entry at the source
Ultimately, for Korean biotech companies to establish themselves in the 600 trillion won market, negotiating power with global big pharma, the speed of listing with local insurers, and overwhelming quality and price competitiveness will be the key factors determining success or failure
