Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.
Celltrion said this week it created a joint venture company in order to pursue the commercialization of 3 biosimilars in China.
Celltrion formed Vcell Healthcare Limited with Nan Fung Group; Vcell also signed a licensing agreement with Celltrion.
Vcell will obtain the exclusive rights in mainland China to develop, manufacture and commercialize 3 biosimilar products from Celltrion: CT-P13 (Remsima, Inflectra, an infliximab product referencing Remicade), CT-P10 (Truxima, a rituximab product referencing Rituxan) and CT-P6 (Herzuma, a trastuzumab product referencing Herceptin).
In addition, Celltrion and Nan Fung Group will explore the opportunity to develop a biologics manufacturing facility in China.
CT-P13, approved in the European Union and the United States is sold in more than 80 countries worldwide. Truxima is also approved in the United States and in Europe; Herzuma carries those approvals as well as approvals in Japan.
Vcell aims to launch the products quickly after following China’s regulatory approval process. If approved, the 3 would join the 1 other approved biosimilar in China, a biosimilar rituximab approved in February 2019 (Henlius’ HLX01). Approval of this rituximab product was a milestone for the Chinese market, as it was not only the first rituximab biosimilar to be approved in the market, but also the first biosimilar to be cleared under the country’s biosimilar approval pathway.
Executives from the 2 companies were enthusiastic about the announcement.
"We are extremely excited about the establishment of Vcell Healthcare Limited, which will serve as the cornerstone for our entry into the Chinese market,” said Seo Jung-Jin, Celltrion’s chairman, in a statement. “We will make our best efforts to start business in China as soon as possible and provide Chinese patients with our outstanding biosimilar products which have already been approved in the global markets such as the US, Europe, and South Korea."
"China has huge unmet medical needs for high quality drugs with affordable prices,” added Antony Leung, chairman and chief executive officer Nan Fung. “We hope Vcell Healthcare Limited could bring world-class biosimilar products to benefit Chinese patients and establish a state-of-the-art manufacturing base in China to serve growing demand for high quality CDMO in the country."
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.