Four Korean drugmakers have obtained approval for generic versions of Amgen's oral psoriasis treatment, Otezla (apremilast).
Daewoong Pharmaceutical, DongKoo Bio&Pharma, Dong-A ST, and Chong Kun Dang will be able to enter the domestic oral psoriasis treatment market abandoned by the original drug.
On Wednesday, the Ministry of Food and Drug Safety (MFDS) approved four apremilast-based formulations -- Dong-A ST's Otelia Tablet, Chong Kun Dang's Otebell Tablet, Daewoong Pharmaceutical's Apsola Tablet, and DongKoo Bio&Pharma's Otemila Tablet.
The four products are generics of Otezla, an oral psoriasis treatment. Amgen’s original drug was the first oral psoriasis treatment approved by the MFDS in November 2017. However, Amgen voluntarily withdrew Otezla's approval in June 2022 after failing to pass the health insurance coverage threshold.
In the meantime, Korean pharmaceutical companies have challenged the launch of generic versions of Otezla, initiating disputes on Otezla's use patent and two formulation patents.
Of the two formulation patents, seven companies – Daewoong, DongKoo Bio&Pharma, Dong-A ST, Mother’s Pharmaceutical, Chong Kun Dang, Cosmax Pharma, and Huons -- filed for passive scope confirmation judgments in September 2020 and July 2021, respectively, and succeeded in avoiding the patent by obtaining a claim validation judgment in the first trial.
The pharmaceutical companies challenging Otezla's generic launch also sought to invalidate Otezla's use patent. However, on Aug. 24 last year, the Intellectual Property Trial and Appeal Board issued a partial rejection and partial dismissal decision.
The trial's outcome meant that Otezla generics could not be launched until after March 18, 2028, when the use patent expires. However, Amgen waived the use of patent rights in a deal with domestic pharmaceutical companies, allowing Otezla generics to be licensed.
According to industry sources, Amgen decided to waive its use patent rights because it had no intention of launching Otezla in Korea after it voluntarily withdrew its license in 2022. Therefore, there was no reason to prevent Otezla generics from entering the market, and the company also did not want to pursue the case further.
The Otezla's use patent is listed as “abandoned” in the Intellectual Property Trial and Appeal Board’s bulletin.
"Although we have received the approval from the MFDS, we expect the commercialization process to take more than six months as it takes time to negotiate the drug price," an official at one of the four companies said, predicting it could be launched as early as early next year.
The official continued, ‘The launch of a generic version of Otezla is an important step in expanding our pipeline of psoriasis treatments to provide patients and healthcare providers with more options, and we are excited about the market potential of an oral psoriasis treatment."