8^th Asian Biologics and Biosimilars Congress

The landscape of multiple sclerosis treatment has changed dramatically over the last decade. As of November 2014, 9 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 percent 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 percent 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 stablished 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.