Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis

Abstract

The multiple sclerosis (MS) treatment landscape in the United States has changed dramatically over the past decade. While many disease-modifying therapies (DMTs) have been approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS, DMT costs continue to rise. The availability of generics and biosimilars in the MS-treatment landscape is unlikely to have a major impact on clinical benefit. However, their availability will provide alternative treatment options and potentially lower costs through competition, thus increasing the affordability of and access to these drugs. In April 2015, the first generic version of the complex drug glatiramer acetate (Glatopa® 20 mg/mL) injection was approved in the United States as a fully substitutable generic for all approved indications of the 20 mg/mL branded glatiramer acetate (Copaxone®) dosage form. Despite glatiramer acetate’s complex nature—being a chemically synthesized (ie, nonbiologic) mixture of peptides—the approval occurred without conducting any clinical trials. Rather, extensive structural and functional characterization was performed to demonstrate therapeutic equivalence to the innovator drug. The approval of Glatopa signifies an important milestone in the US MS-treatment landscape, with the hope that the introduction of generic DMTs and eventually biosimilar DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS.

The influence of glatiramer acetate on Th17-immune response in multiple sclerosis

“…In a clinical trial (ClinicalTrials.gov Identifier: NCT02753088), comparable efficacy and safety of Timexon ® and original GA Copaxone ® has been shown [ 19 ]. However, GA is a complex mixture of synthetic polypeptides with a range of molecular weights and sequences, manufactured by copolymerization of four amino acids (L-glutamine, L-lysine, L-alanine, L-tyrosine) at a specific molar ratio [ 50 ]. Therefore, additional studies to demonstrate equivalence are needed.…”

Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study

“…Copaxone (20 and 40 mg) was initially introduced to the market by Teva Pharmaceuticals 9 ; then, generic versions—glatopa and copemyl 20 mg—were developed in the United States and Europe to expand the availability of GA for patients at a lower price, although there are other generic GAs in Argentina, Mexico, and India. 10 , 11 In Iran, there are more than 70,000 patients with MS, and the cost of long-term treatment with Copaxone is unaffordable for Iranian patients despite the fact that Copaxone is not registered in Iran. Because this immunomodulatory and disease-modifying agent can be used as a first-line treatment for RRMS, Zahravi Pharmaceutical Company developed a brand-generic of GA locally.…”

Therapeutic Nanoparticles and Their Targeted Delivery Applications

“…The conjugation of a glutamate receptor antagonist with a non-polymeric fullerene derivative nanoparticle is able to rescue the clinical progression of chronic MS in an in vivo model [221]. In 2015, Glatopa ® was approved by the FDA as the first generic drug, which is derived from the only therapeutic peptide, also approved by the FDA for the treatment of MS, glatiramer acetate (also known as the Copaxone ® ) [222]. Glatiramer acetate is a random copolymer and a synthetic peptide composed of l-lysine, l-alanine, l-glutamic acid, and l-tyrosine, which could suppress inflammatory responses by blocking MHC-II and changes the population of T-cell [102].…”