Samsung-AZ joint venture contemplates on Mabthera biosimilar

Completed Phase III trial on Mabthera biosimilar completed in August, Phase I in February

No announcement made for two months on prospective plan, could be burdened by the saturated market

Mabthera product image.

A subsidiary of Samsung Biologics, Archigen Biotech (“Archigen”) has successfully completed clinical trials but it has not yet disclosed its further plan on the product in development.

 

While Archigen’s sole portfolio is a Mabthera (rituximab) biosimilar in development, the industry is paying attention to the correlation between Archigen’s silence and the saturated Mabthera biosimilar market.

 

A source from the pharmaceutical industry told on Oct.

 

19, Archigen has completed a Phase III trial on 'SAIT101' treating patients with follicular lymphoma and published the outcome.

 

The study was conducted in the U.S., Europe, Japan and South Korea.

 

According to the clinical trial information website ‘ClinicalTrials.gov’ managed by the U.S.

 

National Institutes of Health (NIH), the study started from June 2016 and ended in last January.

 

The outcome of the study was presented in last August after data analysis.

 

The trial had total 315 participating patients with follicular lymphoma, in which 158 patients were treated with Mabthera and the rest of 157 patients treated with SAIT101.

 

The outcome seemed generally successful.

 

The primary endpoint, overall response rate (ORR) in the Mabthera group marked 70.6 percent and the SAIT101 group marked 66.3 percent.

 

Prior to the disclosure, a Phase I trial outcome comparing the Korean-made biosimilar against Mabthera in treating rheumatoid arthritis was published in last February.

 

The outcome was also deemed successful as the biosimilar’s efficacy was on par with Mabthera.

 

Disclosed information on Archigen’s Phase III trial on SAIT101 treating patients with follicular lymphoma (top) and Phase I trial on treating rheumatoid arthritis (Source: ClinicalTrials.gov)

However, the company has not spoke of any prospective plan on the drug for two months and even for eight months.

 

The industry sources say it is an exceptional case.

 

Usually, a company would announce additional clinical trial or item approval plan around the point of announcing the clinical trial result.

 

Archigen’s parent company, Samsung Biologics gave an explanation in principle only.

 

The company official said, “We would have an opportunity in the future to speak of the prospective plan.” Archigen is a biosimilar-specializing company established in 2014 as Samsung Biologics and AstraZeneca’s joint venture with 50/50 partnership.

 

With that in mind, the South Korean company would not be able to make a prospective plan by itself.

 

Regardless, the pharmaceutical industry has a different view in why Archigen is contemplating for a long time.

 

It is a convincing story that SAIT101, as a latecomer, would not have a favorable position entering the market.

 

At the moment, Celltrion, Pfizer and Sandoz are having a heated competition in the Mabthera biosimilar market.

 

In the European market, Celltrion’s Truxima, Sandoz’ Rixathon, and Pfizer’s Ruxience have been released.

 

And due to the series of biosimilars launched in the market, the original Mabthera’s sales have been halved.

 

Meanwhile, Sandoz has decided to pursue sales in the world’s biggest market, the U.S.

 

with low marketability expected.

 

The industry experts analyze the company felt the strain to enter the market after Celltrion promptly expanded its market share.

 

When launching its latecomer drug Ruxience in the biosimilar market, Pfizer lowered 15 percent of Truxima’s price.

 

On the contrary, some claim Samsung Biologics and AstraZeneca would push ahead with the product launch to retrieve the investment made so far, worth approximately 250 billion won.

 

A pharmaceutical industry source explained, “The Mabthera biosimilar market is a tough one as even Sandoz, considered as the biggest competitor of Celltrion, backed out from the U.S.

 

market and Pfizer also had to lower the price of its follow-on drug by 15 percent,” so “Samsung Biologics would have to make a difficult decision to break through the challenging market.”