Celltrion sets sights on 2017 for EU and US rituximab biosimilar success

By Dan Stanton contact

- Last updated on GMT

Celltrion is based in Songdo, South Korea. Image: iStock/Vichly44
Celltrion is based in Songdo, South Korea. Image: iStock/Vichly44

Related tags: Monoclonal antibodies

Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.

Truxima - also known as CT-P10 – becomes Celltrion’s third biosimilar product to be approved in Korea after 2012’s Remicade (infliximab) biosimilar Remsima, and Herzuma, a version of Roche’s Herceptin (trastuzumab) approved in 2014.

“Celltrion’s Rituxan (rituximab) biosimilar has been granted product approval by Korea’s Ministry of Food and Drug Safety (MFDS) as of November 16th, 2016,”​ a spokesperson for the confirmed, adding includes all indications of Roche’s reference drug including Non-Hodgkin’s Lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

Biopharma-Reporter was told “this important milestone showed robustness of data package of Truxima,” ​and similar results are expected in the EU and the US.

“Celltrion submitted Truxima to the EMA in October 2015 and expects product approval in 2017. US Application will be submitted to US FDA somewhere in early 2017.”

Remsima was approved and launched in the EU in 2013​. In the US, the product is marketed under the name Inflectra by Pfizer and after being approved earlier this year by the US Food and Drug Administration (FDA), the biosimilar is expected to be launched within the next few days​ at a 15% to its reference.

Celltrion is collaborating with Pfizer over a number of biosimilar products, but Truxima – if approved – will be sold by Teva in the US after the Israeli generics firm made an upfront payment of $160m in October​ to commercialise the biosimilar, along with Celltrion’s version of Herceptin.

Celltrion’s biosimilar products, along with its proprietary biologics, are made at its site in Songdo, Korea​ which is expected to boast 310,000L of bioreactor capacity when a third mammalian cell culture facility comes on line in 2021.

AstraZeneca and Samsung Biologics JV

In related Korean rituximab news, Archigen Biotech has received approval from the MFDS to initiate clinical trials on its lead candidate SAIT101, intended to also be a competitor to Roche/Genetech’s Rituxan.

The company was formed in 2014 as a 50/50 joint venture between Anglo-Swedish Big Biopharma AstraZeneca and Korean contract biomanufacturer Samsung BioLogics.

Samsung BioLogics – located near to Celltrion in Songdo – is also involved in other biosimilar projects, owning 91% of Samsung Bioepis which has biosimilars of Enbrel, Remicade, Humira, Lantus, Herceptin, and Avastin in its pipeline.

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