ScinoPharm Secures FDA Approval for Complex Multiple Sclerosis Treatment

ScinoPharm becomes the first Taiwan Company in winning US FDA approval for Glatiramer Acetate injection to cure complex multiple sclerosis treatment.

ScinoPharm Taiwan Ltd, a leading R&D and API manufacturing service provider to the global pharmaceutical industry has received approval from the US Food and Drug Administration (FDA) for its Glatiramer Acetate (Injection for the treatment of Multiple Sclerosis). Gaining this approval, ScinoPharm becomes the first pharmaceutical business in Taiwan to receive FDA approval for this product, demonstrating Taiwan's growing prominence in the global pharmaceutical production scene.

Multiple sclerosis affects over 2.9 million individuals globally. The US National MS Society reports that there are almost one million Multiple Sclerosis sufferers in the United States alone. According to Verified Market Reports, the global market for GA is expected to reach USD 2.8 billion by 2033, up from USD 1.5 billion in 2024.

Glatiramer Acetate has been considered as one of the most difficult complicated synthetic polypeptides in the world since its initial approval in 1996. The drug's different qualities urged the FDA to create a separate regulatory route for Non-Biological Complex Drugs (NBCDs) to handle goods of this nature.

In contrast to traditional small molecules, GA is a peptide copolymer mixture made up of millions of polypeptide chains with different lengths and amino acid sequences rather than a single, distinct entity. As it lacks a fixed molecular structure, the quality control, manufacturing reproducibility, and equivalency assessment are all severely disadvantaged by this complexity.

There could be countless possible variations in the finished product. As a result, manufacturers need to make sure that every process parameter is stable and consistent. To determine product equivalency, more than 40 sophisticated analytical methods backed by statistical modeling are needed, along with biological activity tests to verify that the finished product is, in fact, comparable to the Reference Listed Drug (RLD), Teva Pharmaceuticals' Copaxone.

This accomplishment of FDA approval shows the company's capacity for high-barrier production and confirms its competitiveness with top international pharmaceutical firms. Additionally, the approval signifies ScinoPharm's entry into commercial-stage operations and is the company's first FDA-approved completed medication. Only a small number of businesses globally still have the manufacturing and scientific knowledge needed to create and market Glatiramer Acetate.