Korean biosimilar companies seek approvals as blockbuster drug patents expire

Dong-A ST Co. headquarters [Courtesy of Dong-A ST]

South Korean biosimilar companies are scrambling to gain approvals in major markets, following the patent expiry of a series of blockbuster drugs including Humira, the world’s top-selling drug that acts on the immune system, and autoimmune disease treatment Stelara.

According to multiple industry sources on Thursday, Dong-A ST Co. plans to file a license application for its Stelara biosimilar DMB-3115 in the U.S. and Europe in June.

The patent of Stelara, which saw global sales reach $9.7 billion last year, is set to expire in September in the U.S. and September next year in Europe.

It is the first time for Dong-A ST to enter the major markets with a self-developed biosimilar.

Other biosimilar companies Celltrion Inc. and Samsung Bioepis Co. have also completed phase-three clinical trials for their copied products of Stelara.

Celltrion has finished filing an application for the approval of its product with the European Medicines Agency (EMA) last week.

It is highly likely that Icelandic biosimilar drugmaker Alvotech SA that applied for approval in the U.S. and Europe early this year will be the first to receive approval for a Stelara biosimilar.

The U.S. patent for Eylea, which was jointly developed by Regeneron Pharmaceuticals Inc. of the U.S. and Bayer AG of Germany, expires in June.

Among Korean players, Samsung Bioepis, Celltrion, Samcheondang Pharmaceutical Co., and Alteogen Inc. jumped into the Eylea market that boasts annual sales of $7.7 billion.

Samsung Bioepis and Samchundang Pharmaceutical have completed phase-three clinical trials globally. Samcheondang Pharmaceutical, which will make a debut in the biosimilar market with the Eylea biosimilar SCD411 is pursuing a contract with a European pharmaceutical company for licensing in Europe in July.

Patent litigation, however, emerges as a new risk in the market as Eylea developer Regeneron Pharmaceuticals has filed infringement lawsuits against Viatris Inc. and Samsung Bioepis to defend patent rights.