As Samsung Bioepis won in the first trial to invalidate the patent of Alexion's rare intractable blood disease treatment Soliris (ingredient: eculizumab) in Korea, the possibility of Samsung Bioepis launching SB12, a biosimilar referencing Soliris in Korea has increased.

To sell biosimilars, which are copies of biopharmaceuticals, the original drug's patent must be legally invalidated separately from receiving sales approval from drug regulators.

According to industry sources on Monday, the Korea Intellectual Property Office made a trial decision that partially upheld the patent invalidation trial for Soliris filed by Samsung Bioepis against Alexion.

As the ruling is the first out of three trials, if Alexion appeals, the trial will continue. If Alexion does not appeal, the latest decision becomes final.

The invalidated patent in this ruling is related to methods for treating hemolytic disease.

While the patent is set to expire in 2025, if the recent patent ruling is finalized, Samsung Bioepis will be able to launch the biosimilar successfully.

“Since the partial dismissal is related to claims withdrawn by Alexion, the recent ruling means that all patents related to the treatment have been invalidated,” a Samsung Bioepis official said.

Soliris obtained local approval in 2010 and received an expanded indication for the atypical hemolytic uremic syndrome (aHUS) in Korea in 2016.

SB12 is the seventh biosimilar and the first blood disease treatment developed by Samsung Bioepis. The company applied for approval for the drug to the Ministry of Food and Drug Safety in July 2022.