Considerations on research and development of teriparatide biosimilars
KAN Hong-jin
WEI Wei
CHENG Su-yuan
Abstract：Teriparatide is a peptide drug developed earlier.With the patent expiration of the original drug,its biosimilar is gradually becoming a hot spot for research and development(R&D),and the number of teriparatide biosimilars developed by domestic pharmaceutical companies is gradually increasing.In this paper,we have sorted out the domestic and international registration and R&D status,regulatory status,and use of teriparatide originator and biosimilars,analyzed the technical requirements and challenges of teriparatide biosimilar R&D,and explored the common technical problems in the pharmaceutical development of this kind of products,with a view to providing references to the pharmaceutical development and evaluation of this kind of biosimilars.
Keywords：recombinant sourcespeptidesteriparatidebiosimilars
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 643-649 )