Biosimilar monoclonal antibodies in China: A patent review

ABSTRACT

Biosimilars play an important role in reducing the burden on patients and increasing the market competition. Biosimilar monoclonal antibodies are currently one of the hotspots of research and development in China with policies support. With the continuous improvement of policies, the enthusiasm for the research and development of biosimilars has increased year by year. The policy requirements in different periods have different degrees of impact on the patent applications of pharmaceutical companies. This review introduces the biosimilar monoclonal antibodies market status and approval process in China, analyzes the patents in this field, and helps pharmaceutical companies protect their intellectual property rights.

Graphical Abstract

KEYWORDS:

• Biosimilar
• monoclonal antibody
• Chinese patent
• cancer
• autoimmune disease

Abbreviation

eADA: anti-drug antibody; ADCC: antibody-dependent cell-mediated cytotoxicity; AMD: age-related macular degeneration; AS: ankylosing spondylitis; BC: breast cancer; CD: Crohn’s disease; CLL: chronic lymphocytic leukemia; CRC: colorectal cancer; CTLA-4: Cytotoxic T Lymphocyte antigen 4; DLBCL: diffuse large B-cell lymphoma; DTT: dithiothreitol; EGFR: epidermal growth factor receptor; ELISA: enzyme-linked immunosorbent assay; EMA: European Medicines Agency; FCM: flow cytometry; FCR: fludarabine, cyclophosphamide, and rituximab; FDA: Food and Drug Administration; GC: gastric cancer; HCC: hepatocellular carcinoma; HER2: human epidermal growth factor receptor 2; HNSCC: head and neck squamous cell carcinoma; IL: interleukin; IND: investigational new drug; mAb: monoclonal antibodies; MM: multiple myeloma; MS: multiple sclerosis; NDA: new drug application; NDRC: National Development and Reform Commission; NHL: non-Hodgkin’s lymphoma; NMPA: National Medical Products Administration; NSCLC: non-small cell lung carcinoma; PD-1: programmed cell death 1; PLGF: placental growth factor; PMO: post-menopausal osteoporosis; PS: psoriasis; PsA: psoriatic arthritis; RA: rheumatoid arthritis; RANK: receptor activator of nuclear factor-kappa B; Tcon: conventional T cell; TNF-α: tumor necrosis factor alpha; TOC: total organic carbon; Treg: regulatory T cell; UC: ulcerative colitis; VEGF: vascular endothelial-derived growth factor

Disclosure statement

No potential conflict of interest was reported by the author(s).

Declaration of ethical statement

No ethics approval was required for this study as it involved no human participants or animals.

Additional information

Funding

This work was supported by the Research Project of Jiangsu Cancer Hospital under Grant number ZL202118 and the Research Project of Jiangsu Cancer Hospital under Grant number ZG202101.