Pharmaceutics, Vol. 16, Pages 537: First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product

Pharmaceutics, Vol. 16, Pages 537: First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product

Pharmaceutics doi: 10.3390/pharmaceutics16040537

Authors: Jimena Fernández-Carneado Mariona Vallès-Miret Sílvia Arrastia-Casado Ana Almazán-Moga Maria J. Macias Pau Martin-Malpartida Marta Vilaseca Mireia Díaz-Lobo Mayte Vazquez Rosa M. Sanahuja Gemma Gambús Berta Ponsati

Teriparatide is an anabolic peptide drug indicated for the treatment of osteoporosis. Recombinant teriparatide was first approved in 2002 and has since been followed by patent-free alternatives under biosimilar or hybrid regulatory application. The aim of this study is to demonstrate the essential similarity between synthetic teriparatide BGW and the reference medicinal product (RMP), and thus to ensure the development of the first generic teriparatide drug. Hence, an extensive side-by-side comparative exercise, focusing on structural and biological activity, was performed using a wide range of state-of-the-art orthogonal methods. Nuclear magnetic resonance (NMR), ion mobility–mass spectrometry (IM–MS), UV, circular dichroism (CD) and Fourier transform infrared (FTIR) demonstrated the structural similarity between teriparatide BGW and the RMP. Comparative cell-based bioassays showed that the synthetic and recombinant peptides have identical behaviors. Teriparatide BGW, as a generic drug, provides an available treatment option for patients with osteoporosis and offers clinical benefits identical to those provided by the RMP.