Legal basis for chemical generics with biological reference medicinal product

CMDh recently discussed the applicable legal basis for generic products containing a synthetically manufactured active substance referring to a biotechnological or biological product. Based on a discussion on this topic from 2015, CMDh agreed that such an application should be submitted under Article 10(1). The current discussion focused on the application’s submission under Article 10(3) because (pre-)clinical data might be needed to demonstrate similarity. This discussion concludes that the final selection of the legal basis is the applicant’s responsibility and depends on the regulatory strategy or content of the dossier. The applicants should be aware that if additional (pre-)clinical data would need to be submitted, there is a risk of application rejection using Article 10(1). The revision of the pharmaceutical legislation might provide further clarity on such cases.