Samsung Bioepis loses Eylea appeal trial in the US

'To maintain the order barring the launching"

The U.S. court ruled to maintain a preliminary injunction barring biosimilars launch…the launch of Opuviz has stopped

The launch may be postponed until 2027…Korean companies, such as Celltrion·Sam Chun Dang Pharm, face setbacks

The U.S.

 

market entry of 'Eylea' biosimilar, a treatment for eye diseases, from Samsung Bioepis is stalled.

 

The company recently lost a trial of appeal in addition to the previous motion filed by the developer for a preliminary injunction over a sales ban on an item.

 

According to the biotechnology industry sources on January 31, the United States Court of Appeals for the Federal Circuit ruled in favor of Regeneron over a preliminary injunction filed by Regeneron against Samsung Bioepis regarding the sales of Eylea biosimilars.

 

According to the biotechnology industry sources on January 31, the United States Court of Appeals for the Federal Circuit ruled in favor of Regeneron over a preliminary injunction filed by Regeneron against Samsung Bioepis regarding the sales of Eylea biosimilars.

 

The court stated, "Samsung Bioepis failed to present evidence that Eylea biosimilar does not infringe on Regeneron's patent." Further adding, "Regeneron is likely to suffer irreparable harm without preliminary relief.

 

Therefore, the court will hold a restraining order barring the launch of Samsung Bioepis' Eylea biosimilar in the U.S.

 

market."

In late 2023, Regeneron filed a lawsuit against Samsung Bioepis for infringing on 51 Eylea patents.

 

During the trial, Regeneron filed a motion to the court for a temporary restraining barring Samsung Bioepis from launching Eylea biosimilar 'Opuviz' in the U.S.

 

market.

 

After that, in June 2024, the U.S.

 

District Court for the Northern District of West Virginia granted this claim and approved the barring of Opuviz's entry into the U.S.

 

market.

 

Samsung Bioepis appealed against this preliminary injunction and immediately filed a notice with the appeals court.

 

As Samsung Bioepis lost the appeals trials, the entry of Opuviz in the U.S.

 

market has become uncertain.

 

Eylea, jointly developed by the U.S.-based Regeneron and Germany-based Bayer, is a treatment for eye diseases.

 

It is used to treat various eye diseases, including macular degeneration, macular edema, and diabetic retinopathy.

 

Currently, Eylea ranks No.1 worldwide among the treatments for wet age-related macular degeneration (AMD).

 

Last year, it recorded global sales of US$9.36 billion (approximately KRW 12 trillion), accounting for the major market.

 

For Regeneron, Eylea is a major cash cow, accounting for 70% of the total sales.

 

Given that follow-up pharmaceuticals are unavailable, Regeneron has prepared a tight defensive strategy to stop the launch of biosimilars.

 

In addition to existing substance patent, the company has prepared for various patents, such as the use patent, formulation patent, and a specified prescription group, or proceeding with trials to prevent competitors from entering the market.

 

In the worst case, the U.S.

 

launch of the Eylea biosimilar could be postponed until 2027.

 

The U.S.

 

substance patent for Eylea will expire this May, but the additional patent is set to expire on June 14, 2027.

 

It is possible that the ruling could be overturned at the appeal court or Samsung Bioepis to negotiate with Regeneron.

 

However, if both companies were to negotiate, Samsung Bioepis must pay Regeneron the royalty fee and compensation.

 

Given the current appeal court result, Korean companies, such as Celltrion and Sam Chun Dang Pharm, that aim to enter the Eylea biosimilars market face setbacks.

 

Regeneron is proceeding with the Eylea biosimilar lawsuit with these Korean companies and other companies, including Amgen, Mylan, and Biocon.

 

Samsung Bioepis remarked, "We are unable to make an officially statement regarding the legal disputes."