The US Food and Drug Administration has approved a generic glatiramer acetate injection developed by ScinoPharm Taiwan for the treatment of relapsing multiple sclerosis, marking the first approval of a complex injectable generic for this indication.
Glatiramer acetate, first approved in 1996 under the brand name Copaxone, is a non-biological complex drug composed of synthetic polypeptides and has long been regarded as challenging to replicate. The newly approved product has the same active ingredient, indications, route of administration and strengths as Copaxone, and is intended to be used in the same way for patients with relapsing forms of multiple sclerosis.
The approval was granted through the FDA’s abbreviated new drug application pathway for non-biological complex drugs. This regulatory route allows manufacturers to waive traditional clinical bioequivalence trials provided that the generic product demonstrates close structural and compositional matching to the reference drug, alongside robust in vitro and in vivo evidence of functional similarity. ScinoPharm has not reported conducting phase 2 or 3 clinical trials in multiple sclerosis for this product, instead relying on analytical, functional and quality data in line with FDA guidance.
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ScinoPharm has highlighted that it uses its own proprietary synthesis and purification processes for the glatiramer acetate polymer, with stringent quality controls designed to ensure consistency. As with other approved generics, minor differences from the reference product are permitted, such as syringe design or packaging, provided these do not affect clinical performance.
Evidence supporting the equivalence of high-quality generic glatiramer acetate products comes from previous studies, including the GATE trial published in 2015. That large phase 3 study demonstrated equivalent efficacy between a generic glatiramer acetate and brand Copaxone on MRI outcomes and relapse rates in relapsing-remitting multiple sclerosis.
The approval comes amid continued interest in alternative glatiramer acetate formulations, including long-acting depot preparations, although such products have faced recent regulatory setbacks. Overall, the decision is expected to increase treatment choice and competition in a well-established disease-modifying therapy class for multiple sclerosis.
This news item has been summarised using AI and checked by humans before publication.
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