When medicinal products are used in combination with other already authorised medicinal products, the combination partners should be stated in the product information texts with the active substance name rather than the trade name. Up to now, this ruling has applied explicitly to synthetically manufactured combination partners. It now applies independently of the manufacturing process (synthetic or biotechnological/biological) for the combined indicated medicinal products, i.e. it applies equally to all combination partners.
The initial decision to require the active substance name only for synthetically manufactured combination partners was based on the limited experience available at that time with medicinal products manufactured using biotechnological/biological processes and their biosimilars. However, the practical experience that has since been acquired with authorised biosimilars in Switzerland and globally has not raised any concerns relating to safety or efficacy.
The active substance in a biosimilar and its reference product is essentially the same biological substance, although minor differences may exist as a result of the manufacturing process. By authorising the biosimilar, Swissmedic confirms that possible differences do not affect its safety or efficacy. Subject to an appropriate scientific review of all the data for a biosimilar generated by the applicant in comparability studies with the reference product – including regulatory experience and an acceptable scientific rationale – the efficacy and safety can be extrapolated to other indications of the reference product, including combination therapies (see the guidance document Authorisation biosimilar HMV4).
The practice of naming the combination partners only with the active substance names (DCI/INN according to WHO) is in line with that of foreign regulatory authorities, particularly the EMA and FDA, which serve as the basis for the authorisation of biosimilars by Swissmedic according to Art. 13 Therapeutic Products Act (TPA) in conjunction with Art. 17 Therapeutic Products Ordinance (TPO). This harmonisation of practice is crucial, since Swissmedic is extending its international collaboration with partner authorities for the review of authorisation applications. This is driven by political will and has already been initiated with the Revision of the TPA (TPA2/TPO4), which entered into force on 1 January 2019.
The new requirement and associated changes to the guidance document Product information for human medicinal products HMV4 apply from 1 November 2020. The revised guidance document also contains various clarifications and changes in section 2 (Notes on the Information for healthcare professionals) including, for example, modified article numbers arising from the revised FDHA Ordinance of 1 July 2020 on Genetically Modified Foodstuffs (GMFO, section 2.2.3), clarification concerning adverse reactions (section 2.11), information regarding unknown frequency of occurrence (section 2.11.2), information on the labelling of medicinal products authorised exclusively for use in hospitals (Art. 26 para. 4 TPO, section 2.18) and clarification concerning the warnings to be used for pharmaceutical excipients of particular interest as per Annex 3a of the Therapeutic Products Licensing Requirements Ordinance (TPLRO).
As regards product information texts that have already been reviewed and approved by Swissmedic but that do not yet comply with the new requirements on the naming of combination partners, the marketing authorisation holders are obliged to modify the texts on their own initiative by 31 October 2021 at the latest and notify Swissmedic when these have been implemented.