Why EMA should provide clearer guidance on the authorisation of non-biological complex drugs (NBCDs) in generic and hybrid applications

Why EMA should provide clearer guidance on the authorisation of non-biological complex drugs (NBCDs) in generic and hybrid applications - Livio Garattini

2:10 PM - 2:50 PM


The session will explain the main categories of off-patent medicines and the three types of EMA-abbreviated procedures, to assess the consistency between types of products and applications. Focus will be on non-biological complex drugs (NBCDs) - a subcategory of products that incur regulatory uncertainty once patents expire. The NBCDs are medicinal products with an active substance that is not a homo-molecular structure; a well-controlled manufacturing process is fundamental to reproduce the product.
The application for marketing authorisation of drugs with expired data protection in the EU comes under Directive 2001/83/EC, which identifies 3 different abbreviated procedures: generic, hybrid, and bio-similar. A hybrid procedure is requested when a chemical product does not fully correspond to the definition of a generic, so its bioequivalence with a reference product cannot be demonstrated simply through bio-availability studies (Art. 10(3) of Directive 2001/83/EC). A bio-similar dossier must include an extensive head-to-head comparison with the originator product to ensure close resemblance in physicochemical and biologic characteristics, safety, and efficacy (Art. 10 of Directive 2001/83/EC).
The European marketing authorization for drugs with expired data protection should be exhaustive and unquestionable, to discourage any legal controversy and potential reimbursement delays.
The session will explain the different procedures and the challenges with registration of off-patent medicines