Drug Regulators, EMA (EMEA), Publish Concept Paper on Similar Biological Products Containing Recombinant Interferon Beta.

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Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS), which is particularly frequent in Europe and one of the most common causes of neurological disability in young and middle-age adults; the social and economical burden of the disease is thus considerable. Most patients (80-90%) develop the relapsing-remitting form of the disease (RRMS), which is characterised by episodes of neurological symptoms separated by periods of relative stability. About 50-70% of these patients eventually enter a phase of progressive neurological decline (secondary progressive MS) with or without superimposed relapses. The pathogenesis of the disease remains unsolved but it is believed to be predominantly an organ- or antigenic-specific autoimmune disease mediated by activated T-lymphocytes, which cross the blood brain barrier (BBB) and initiate a series of inflammatory events that result in demyelination and irreversible axonal loss.

Recombinant interferon beta (INF-β) is currently the mainstay of MS disease-modifying therapies. Endogenous human INF-β is a cytokine secreted by various cells in response to viral infection. A member of the INF type I family, it binds to its specific receptor IFNAR and regulates the transcription of hundreds of genes. The mechanism of action of INF-β in MS is not well established but it has been hypothesized that it acts as an immunomodulator by 1) interfering with T-cell activation in several ways, including downregulating the expression of Type II MHC molecules, inhibiting the production of pro-inflammatory cytokines by Th1 cells, promoting the production of anti-inflammatory cytokines by Th2 cells, activating suppressor T-cells and 2) inhibiting the destruction of the BBB and the infiltration of T-cells into the CNS.

Recombinant INF-β products are currently being developed as similar to products approved in the EU. A product-class specific guidance will lay down specific (non)clinical requirements for the demonstration of similarity of two recombinant INF-β containing products through a comparability exercise.

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