European
Commission have issued a final guideline comes into effect 30 April 2015
although applicants may make use of it prior to that date.
The
guideline outlines the general principles to be applied for similar biological
medicinal products (biosimilars) as referred to in Directive 2001/83/EC, where
it is stated that „the general principles to be applied [for similar biological
medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the
Agency‟. This Guideline describes and addresses
the application of the biosimilar approach, the choice of the reference product
and the principles for establishing biosimilarity.
Posted by Tim Sandle
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