Under surveillance: generic and biosimilar MAs

In order to be well prepared before a generic or biosimilar marketing authorisation is approved, drugs companies in the EU may consider monitoring pending applications, says Ruth Franken of Hogan Lovells.

Regulatory surveillance includes a variety of options for drug companies and other stakeholders to monitor future and pending marketing authorisation applications (MAAs). EU regulatory surveillance allows companies to monitor whether generic or biosimilar MAAs are pending in the EU. This allows companies to prepare for the launch of a competitor product or potential advocacy and litigation activities. Such activities should be carefully considered in light of competition law, and may be aimed at protecting regulatory data protection and market exclusivity rights, and/or patent and supplementary protection certificates.

The surveillance options depend on the type of MAA procedure that is followed. The centralised procedure—which is based on Regulation (EC) No. 726/2004—provides for a single application, evaluation and authorisation allowing direct access to the entire EU market. The centralised procedure is mandatory for certain medicinal products, eg, those intended to treat cancer, diabetes, HIV, and medicinal products derived from biotechnology processes such as genetic engineering, etc.

The centralised procedure is optional for other medicinal products, eg, in the interest of public health at an EU level if the reference product was approved at that level, etc. MAAs for medicinal products that fall within neither the mandatory scope nor the optional scope should be submitted through either the decentralised procedure, mutual recognition or national procedure at EU member state level.