Four Otezla generics were authorized simultaneously in Korea

After overcoming the patent of Amgen’s original drug Otezla, which had withdrawn from the market

Amgen revokes rights for Otezla’s ‘composition and method of use’ rights after withdrawing its marketing authorization in Korea

Daewoong, Dong-A, DongKoo, and CKD will immediately apply for reimbursement of their Otezla generics

Amgen

Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea.

 

With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent seem to have applied for approval of their generic versions at once.

 

On the 17th, the Ministry of Food and Drug Safety approved four apremilast-based formulations, including Dong-A ST's ‘Otelia Tab,’ Daewoong Pharmaceutical's ‘Apsola Tab,’ Dongkoo Biopharm’s ‘Otemila Tab,’ and Chong Kun Dang’s ‘Otebell Tab.’ Otezla, the original apremilast formulation of these generics, was the first oral psoriasis treatment to be approved by the MFDS in November 2017, but the company voluntarily withdrew the drug’s license in June 2022 after failing to cross the reimbursement threshold.

 

In the process, domestic pharmaceutical companies began filing patent suits to launch their generic versions of Otezla.

 

Otezla has 3 registered patents, including a use patent (10-0997001) and two formulation patents (10-2035362 and 10-2232154).

 

In the case of the 2 formulation patents, 7 companies, including Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, Huons, Chong Kun Dang, Mothers Pharm, and Cosmax, filed to confirm the passive scope of rights in May 2021 and November 2022 and succeeded in avoiding the patents.

 

However, the companies still had to overcome the use of patents to launch their generic versions.

 

Otezla’s use patent was set to expire on March 18, 2028.

 

The companies must invalidate the use patent as well to launch their generic versions, and on August 24 last year, the court decided to ‘partially reject and dismiss’ the use patent’s invalidation trial.

 

Despite withdrawing from the Korean market, Amgen appeared to be vigorously defending its patent rights, leading to criticism that it was blocking the entry of generics that were preparing to launch in Korea.

 

And with no further news of the domestic pharmaceutical companies filing appeals to evade the use of patents since August last year, the news of the 4 generic Otezla approvals drew attention to their background.

 

A representative from a relevant Korean pharmaceutical company said, "We have been continuously making an agreement with Amgen regarding the use of the patent.

 

Amgen withdrew its license for Otezla in 2022 and had no intention of launching it in the future, so there was no reason to prevent generics from entering the market." "Amgen said that it didn't want to continue litigating a product that they had no intention of launching in the country.

 

They agreed that the patent would not be a barrier to generic entry in the future, which is why we went through the process." Currently, the legal status of Otezla's use patent, (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of synthesis and compositions thereof" is indicated as “revoked," according to Korea’s Intellectual Property Trial and Appeal Board bulletin.

 

An industry official said, "The Otezla generics have not been jointly developed by the companies, but seem to have been approved at the same time upon the resolution of the patent issue.

 

We plan to apply for reimbursement immediately upon approval and start drug price negotiations."