Tony Hagen is senior managing editor for The Center for Biosimilars®.
Celltrion is pinning its hopes on a higher-concentration formulation of adalimumab to gain elbow room among multiple competing products.
Hoping to grab a share of the increasingly competitive market for adalimumab in the European Union, Celltrion has sought marketing approval for its adalimumab biosimilar, CT-P17, from the European Medicines Agency. An immediate launch is planned once authorization is granted.
The company has tweaked the adalimumab product slightly to give it an edge in the increasingly crowded market for adalimumab.
Based on an application filing in March, the company hopes to gain approval for all indications of AbbVie’s reference product Humira, including rheumatoid arthritis, ulcerative colitis, and psoriasis.
In Europe in 2019, sales revenue for Humira continued to decline owing to encroaching biosimilar competition that now includes a field of at least 6 products: Amgevita, Imraldi, Halimatoz, Hulio, Kromeya, and Amsparity. European net revenues for Humira amounted to $4.3 billion in 2019, down 31.1%.
Celltrion is seeking approval for a high-concentration formulation of CT-P17 that it hopes will differentiate the product from competitors.
Product differentiation has been a successful technique for Celltrion. It previously introduced a subcutaneous version of its infliximab biosimilar (sold as Inflectra in the United States and Remsima in the European Union), as opposed to intravenous.
The company said the new version had comparable efficacy and safety for patients with Crohn disease and rheumatoid arthritis.
In an early 2020 report for its investors, Celltrion reported that Remsima had achieved a 59% share of the European market for infliximab, a larger share than retained by the reference product by Janssen, Remicade.
The ambitious launch schedule for the adalimumab biosimilar is in tune with the company’s plans expand rapidly into the biosimilar space.
‘‘Celltrion boasts a strong and dynamic product portfolio and pipeline. As we chart the company’s 2030 vision, the company hopes to launch 1 biosimilar product every year, reaching a total number of 18 products by 2030. Biosimilars and value-added medicines which we call bioinnovatives [innovative biosimilars] are set to be our key growth drivers,” said Jung Jin Seo, Celltrion’s chairman, in a statement.
In Europe, the company’s rituximab (Truxima) and trastuzumab (Herzuma) biosimilars have achieved market shares of 38% and 15%, respectively.
In the United States, where AbbVie has managed to retain full market share for Humira, net revenues for reference adalimumab in 2019 were $14.9 billion. There are 5 adalimumab biosimilars currently approved by the FDA and these are anticipated to launch in 2023.
In March, Teva Pharmaceuticals USA and Celltrion Healthcare announced the market availability of Herzuma (trastuzumab-pkrb), an injectable biosimilar with the same indications as the Herceptin reference product.