Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for the drug.
Rituximab, known for the brand names MabThera and Rituxan, is a CD20 monoclonal antibody originally developed by Roche and introduced in China in March 2000. Since February 2019, Henlius’s Hanlikang has been approved for use in non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA) in China. Henlius has previously entered into a licensing agreement with FARMA DE COLOMBIA S.A.S for the commercialization of Hanlikang in Colombia, Peru, Ecuador, and Venezuela.
The approval from Peru’s DIGEMID is based on a series of study results, with the filing based on the New Drug Application (NDA) submitted to the National Medical Products Administration (NMPA) in China. Head-to-head studies conducted for Hanlikang have demonstrated its high similarity to the originator drug in terms of quality, safety, and efficacy.- Flcube.com
