TY - JOUR
T1 - Development of Glatopa® (Glatiramer Acetate)
T2 - The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis
AU - Bell, Christine
AU - Anderson, James
AU - Ganguly, Tanmoy
AU - Prescott, James
AU - Capila, Ishan
AU - Lansing, Jonathan C.
AU - Sachleben, Richard
AU - Iyer, Mani
AU - Fier, Ian
AU - Roach, James
AU - Storey, Kristina
AU - Miller, Paul
AU - Hall, Steven
AU - Kantor, Daniel
AU - Greenberg, Benjamin M.
AU - Nair, Kavita
AU - Glajch, Joseph
N1 - Publisher Copyright:
© The Author(s) 2017.
PY - 2018/10/1
Y1 - 2018/10/1
N2 - 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.
AB - 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.
KW - disease-modifying therapy
KW - generic drugs
KW - glatiramer acetate
KW - multiple sclerosis
UR - http://www.scopus.com/inward/record.url?scp=85046160714&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85046160714&partnerID=8YFLogxK
U2 - 10.1177/0897190017725984
DO - 10.1177/0897190017725984
M3 - Review article
C2 - 28847230
AN - SCOPUS:85046160714
SN - 0897-1900
VL - 31
SP - 481
EP - 488
JO - Journal of Pharmacy Practice
JF - Journal of Pharmacy Practice
IS - 5
ER -