Amgen won the second trial of 'Enbrel' patent

Is Samsung Bioepis postponed again?

In the final result, it was decided that the early launch of the similer

Samsung Bioepis, Benepali in Europe, and Eticovo in US

Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut.

 

A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company.

 

According to the pharmaceutical industry on the 6th, the U.S.

 

Federal Court of Appeals earlier this month has sided with the original company in a patent lawsuit between Enbrel's patentee, Immunex and biosimilar maker Sandoz.

 

Immunex is a subsidiary of Amgen.

 

This is the same result as the first trial made by the New Jersey District Court.

 

The court respected the original trial that Sandoz company's failure to provide sufficient grounds to prove Amgen's patent invalidity.

 

As a result, Amgen succeeded in maintaining and defending Enbrel's patent until 2029.

 

However, the possibility of reversal remains.

 

Immediately after the second trial was announced, Sandoz announced its intention to appeal the third trial.

 

The reason that Sandoz and Amgen's litigation has attracted attention is that this ruling also affects Samsung Bioepis' Eticovo.

 

Sandoz and Samsung Bioepis are actually in a patent dispute with Amgen.

 

Enbrel biosimilar ‘Erelzi’ by Sandoz was approved by the U.S.

 

Food and Drug Administration (FDA) in 2016.

 

Eticovo by Samsung Bioepis was approved in April 2019.

 

However, the two companies are unable to release products to the US market.

 

They have the challenge of overcoming Amgen's patent.

 

It is analyzed that Eticovo’s case is likely to follow the results of Erelzi’s case.

 

It means that it is also determined whether Eticovo will be launched early according to the results of the patent lawsuit between Sandoz and Amgen, which will be judged by the US Supreme Court.

 

Samsung Bioepis is actually watching the lawsuits between Sandoz and Amgen.

 

It is said that there is no full-scale pleading after the lawsuit under the licensed patent linkage system began in April of last year.

 

An official from Samsung Bioepis said, "We are watching the results of the lawsuit between Sandoz and Amgen." Samsung Bioepis currently has four biosimilars in the United States.

 

Eticovo, Remicade biosimilar 'Renflexis', Humira biosimilar 'Hadlima', and Herceptin biosimilar 'Ontruzant', etc.

 

Of these, Renflexis and Ontruzant are currently on sale.

 

Eticovo & Hadlima have been postponed due to patent.

 

However, Hadlima can be released after 2023 according to an agreement with the original company, AbbVie.