Equal First or Equal Last?

E

Comparison of Copaxone® and Synthon’s therapeutically equivalent glatiramer acetate. Arends RJ, Wang D, Buurman M, Luten J, Koper NP, Wolf C, Scheren M. Pharmazie. 2019 ;74(8):449-46.

Glatiramer acetate is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS). In 2016, an alternative to the originator product was approved in the EU through the hybrid procedure regulatory pathway. This paper reviews the scientifically rigorous and multifaceted program undertaken to demonstrate the equivalence of this glatiramer acetate follow-on product (GTR) and the reference product Copaxone®, which resulted in the EU approval of GTR 20 mg/mL and 40 mg/mL. Establishing therapeutic equivalence for non-biological complex drugs is not trivial and requires a complex and multidisciplinary effort. Ultimately, there is not a single test or study that establishes therapeutic equivalence of two heterogeneous products. Instead, it requires a good understanding of the synthesis process together with a full set of data that includes comparative physicochemical testing, nonclinical in vitro and in vivo studies, and a comparative clinical study to allow for a valid conclusion that two products are therapeutically equivalent. The detailed understanding of glatiramer’s synthesis process and its impact on the characteristics of glatiramer, combined with the results of a scientifically rigorous and multifaceted physicochemical and biological characterization program, and the clinical data from the 794-patient Phase III GATE study, demonstrate that GTR and Copaxone are therapeutically equivalent. The data further demonstrate that Synthon’s manufacturing process consistently yields drug substance of the same quality as Copaxone and that switching from Copaxone to GTR is safe and well-tolerated.

GA is the biggest selling DMT on the MS market, Teva has had the market from invention in the 1970s to 2014 to itself, but now competitors are about. Glatiramer acetate is a random mix of 4 amino acids and therefore one batch of drug is probably not the same to the next batch.

When competitors come along, the originator claims theirs is the original and best. However, others have now convinced the regulators that their variants are just as good .

However is it equivalent to being the bee’s knees , the dog’s bol***ks or the the dog’s breakfast?.

COI: Multiple but no relevant for these agents, ProfG conflicted to the max:-)

About the author

MouseDoctor

1 comment

By MouseDoctor

Translate

Categories

Recent Posts

Recent Comments

Archives