The biosimilars in China just started, and the biosimilar review and approval policies continue to be improved. It is predictable that there will be many biosimilars approved for marketing by China Food and Drug Administration (CFDA) during 2016-2020. I find after searching the website of the Center for Drug Evaluation of CFDA that the R&D varieties of biosimilars in China mostly target global blockbuster monoclonal antibody drugs such as Humira, Herceptin, Remicade, and Avastin. For every variety, there are several companies with products under clinical or preclinical phases. I summarize the latest developments of R&D of each biosimilar after searching each product.

I. "Drug king" Humira: Chinese enterprises compete to imitate it, wherein, Bio-Thera and Innovent Biologics are at the forefront

I believe that everyone has heard about the name of the "drug king" Humira that brings over USD 16 billion revenue to AbbVie every year. This drug entered the Chinese market on February 26, 2010, however, Humira’s performance on the Chinese market has been barely satisfactory due to competition of like products (such as Enbrel and Yisaipu) and the low rate of knowing of rheumatoid arthritis, but the charm of the "drug king" Humira is still irresistible: currently there are over 20 Chinese companies developing relevant biosimilar products, wherein, the relevant products of Innovent Biologics, Bio-Thera, and Henlius are at the forefront, especially, the HLX03 of Shanghai Henlius has obtained the clinical approval for the two indications: rheumatoid arthritis and psoriasis, which is quite a characteristic.

II. Baimaibo, the biosimilar of Remicade, has been applied for production

Remicade, generic name: infliximab, targets the tumor necrosis factor (TNF)-α, and belongs to chimeric human-mouse monoclonal antibody; it was marketed in the U.S. in 1998, and in China in 2007. The annual sales of this original drug are about RMB 100 million after entering the Chinese market, which are tepid. Currently, Shanghai Biomabs has applied for production of relevant biosimilar product, which is the fastest, with the product under clinical self-inspection.

III. Avastin: Many biosimilar varieties have entered Phase III clinical trial

Avastin, generic name: bevacizumab, is a humanized IgG1κ monoclonal antibody that targets the tumor cell vascular endothelial growth factor (VEGF). In China, relevant products of Innovent Biologics, TOT Biopharm, Qilu Pharmaceutical, and Mabworks develop faster, while products of other companies are under early clinical or preclinical development. It’s worth noting that there is also a Chinese biosimilar for the above target that is developed for wet age-related macular degeneration.

IV. Herceptin: Saiputing of Sunshine Guojian

Herceptin, generic name: trastuzumab, is a humanized IgG1κ monoclonal antibody that targets HER2 on tumor cell surface; it was marketed in the U.S. in 1998, and entered the Chinese market in 2002, for HER2+ breast cancer, gastroesophageal junction adenocarcinoma, and metastatic gastric cancer. Saiputing of Sunshine Guojian was withdrawn application for production in clinical self-inspection, while the products of Henlius, Genor Biopharma, and Anke Biotechnology have entered Phase III clinical trial, which are worth expecting.

V. Rituxan biosimilar of Henlius: the first biosimilar formally applied for production in China

Rituxan, generic name: rituximab, targets CD20, and belongs to chimeric murine/human monoclonal IgG1 Kappa antibody; it was marketed in the U.S. in 1997, and entered China in 2008. The rituximab injection biosimilar developed by Henlius, i.e., recombinant chimeric mouse-human anti-CD20 monoclonal antibody injection, is used to treat non-Hodgkin lymphoma (NHL), with the pharmaceutical product registration accepted by CFDA for review, being the first biosimilar formally applied for production in China. The Jiantuoxi of Sunshine Guojian belongs to a variety under clinical self-inspection, and has been withdrawn.

Click to read:  Current Situation of Biosimilars in China I: A Focus on the Biosimilar Market in China