Under surveillance: generic and biosimilar MAs

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.