Alvogen targets the Korean market with a Spanish biosimilar

Alvogen’s Avastin biosimilar is approved in Korea

Developed by mAbxience in Spain… approved in Europe last year

Third latecomer to enter market… enters before Celltrion

Alvogen’s Korea is attempting to target the domestic anticancer drug market with a Spanish biosimilar.

 

Its product is the third Avastin (bevacizumab) biosimilar to enter the market after Samsung Bioepis and Pfizer.

 

On whether the new biosimilar will become a new sensation among latecomers in the market and is gaining attention.

 

On the 19th, the Ministry of Food and Drug Safety approved Alvogen Korea’s ‘Arimsis inj.’ a monoclonal antibody treatment for cancer that contains the same ingredient as Roche Korea’s ‘Avastin inj.’ A clinical trial on 625 healthy male adults or patients with advanced or metastatic non-squamous non-small-cell lung cancer was conducted to assess the drug’s equivalence in pharmacodynamics and efficacy to its comparator.

 

The drug's pharmacodynamic equivalence was demonstrated in 114 healthy male adult participants who received 'Arimsis' and its comparator Avastin.

 

Also, the efficacy of the drug was verified through a study on 511 patients with advanced or metastatic non-squamous non-small-cell lung cancer.

 

Results showed that the objective response rate (ORR) of the patients was statistically equivalent to that of its comparator.

 

Until now, only a few biotech companies attempted to develop biosimilars due to the large-scale facilities required.

 

Through active investment in such facilities, the Korean companies Celltrion and Samsung Bioepis have been dominating the global biosimilar market.

 

However, global pharmaceutical companies have also recently joined in the competition.

 

Amgen&Allergan and Pfizer received US FDA's approval for their Avastin biosimilars.

 

Also, Samsung Bioepis and Celltrion are attempting to receive FDA approval for their Avastin biosimilars.

 

In Korea, Samsung Bioepis’ ‘Onbevzi,’ and Pfizer’s ‘Zirabev’ received approval one after another and are soon to compete in the domestic market.

 

Alvogen’s biosimilar ‘Arimsis’ was developed by a less well-known Spanish pharmaceutical company, mAbxience Research.

 

mAbxience is a biotech company that specializes in the development of biosimilars.

 

The company, which was established in 2020, had been developing biosimilars of Mabthera (rituximab) and Avastin (bevacizumab).

 

Its Avastin biosimilar was first approved in Latin America in 2016, then approved by the European Commission last year.

 

The company has applied for the drug’s approval to the US FDA in June last year.

 

Alvogen succeeded in becoming the third Avastin biosimilar to be approved in Korea using mAbxience’s product that had already been approved overseas.

 

In particular, this product has the same indication as Avastin.

 

Avastin and Arimsis are indicated for ▲metastatic colorectal cancer ▲metastatic breast cancer ▲non-small cell lung cancer ▲ advanced or metastatic renal cell carcinoma ▲glioblastoma ▲epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, and ▲cervical cancer.

 

On the other hand, the indication for Samsung Bioepis’s ‘Onbevzi inj.’ excludes second-line treatment of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer to evade Avastin’s use patent.

 

Alvogen first filed a trial to invalidate the use patent of Avastin in August.

 

Samsung Bioepis also joined in the patent challenge after Alvogen filed the claims.