Celltrion is a biological drug manufacturer based in South Korea. Its rituximab biosimilar (Truxima) was the first biosimilar approved for the treatment of non-Hodgkin’s lymphoma [1], markets for which have been expanding both domestically and overseas [2].

The company recently announced its membership of the Australian Generic and Biosimilar Medicines Association (GBMA) which will allow Celltrion to sell Truxima, as well as its newer breast cancer biosimilar trastuzumab Herzuma to the Australian population.

The GBMA represents companies that manufacture generic and biosimilar medicines in Australia, accounting for 90% of the generic drugs dispensed in Australia. As part of a renewed focus on biosimilar drugs, the GBMA has recently launched a ‘Biosimilar Membership’ to support biosimilar manufacturers, of which Celltrion is the first company to join.

Celltrion also produces infliximab biosimilar Remsima. Infliximab is sold by Janssen Biotech (a Johnson and Johnson company) as Remicade and can be used for a number of inflammatory conditions including inflammatory bowel disease, arthritis and psoriasis.

Altogether, the three compounds have an estimated worth of AUS$280 million in the Australian market, although Remsima is yet to be approved by the Australian authorities. Truxima was approved in March and Herzuma in July 2019, allowing both to be launched onto the Australian market in a direct sales system.

Celltrion Healthcare CEO Kim Hyoung-ki said: ‘By joining the GBMA, we look forward to engaging positively to support the uptake of biosimilars in Australia’. Marnie Peterson of the GBMA added: ‘The addition of our newest member underscores the evolution of GBMA’s role within the Australian healthcare framework’.

In more good news for the company, a clinical trial has been started for its Xolair (omalizumab) biosimilar, currently known as CT-P39. Omalizumab is an anti-allergy drug approved for the treatment of asthma and hives. It made global sales of USS$2.7 billion for developers Genentech and Novartis in 2018, but the US patent expired in December 2018.

Celltrion’s phase I trial will include safety and pharmacokinetic assessments, before phase III clinical trials begin in 2020. The company plans to commercialize the drug by 2022.

A Celltrion official commented: ‘Celltrion will do its best to acquire first-mover status for Xolair biosimilar so that more patients can receive treatment at a reasonable cost’. The original manufacturer however are trying to expand the approved indications for the drug.

Related articles
Real-world data confirms safety of infliximab biosimilar CT-P13

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb)

South Korea increases investment in biologicals

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima  
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion has renewed success with leukaemia biosimilar Truxima and expands markets in Europe and Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Pharma-News/Celltrion-has-renewed-success-with-leukaemia-biosimilar-Truxima-and-expands-markets-in-Europe-and-Latin-America 

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