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The landscape of multiple sclerosis treatment has changed dramatically over the last decade. As of November 2014, nine
disease-modifying therapies (DMTs) for MS have been approved by the US Food and Drug Administration (FDA). Despite
the availability of more treatment options, costs for all MS DMTs have increased sharply. First-generation DMTs, originally
costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times
higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25-60% higher than existing
DMTs. It is predicted that biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to
2024 or about 4% of total biologic spending over the same period, with a range of $13 billion to $66 billion in USA. While the
EU biosimilars market is relatively new, studies suggest that biosimilars in some therapeutic areas are priced below reference
biologics, often with discounts of 25% or more. At the present time, approximately 50% of patients with multiple sclerosis
in Iran are on treatment in which 2/3 are on biosimilars. Of note, the efficacy and safety of such products were assessed and
established in different experimental and clinical controlled studies. Biosimilars will need to compete with their reference
product on the basis of quality, price and manufacturer's reputation with physicians, insurers and patient groups. The prospects
for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should
increase over time because of both demand and supply side factors.
Hossein Pakdaman was graduated in Neurology from the Pennsylvania and Henry Ford University in 1976. He is a Professor of Neurology affiliated to Shahid Beheshti University School of Medicine since 1990, President of Iranian Neurological Association since 1991 and the Director of Iranian Neurological Board Examination since 1978. Also, he has published more than 40 papers in international journals and is the Chairman of Iranian Journal of Neurology since 1998.