The European Commission have released a consultation regarding which products are to be considered similar under Commission Regulation 847/2000. If a medicinal product is considered similar to an OMP under exclusivity, a marketing authorisation may generally not be granted for 10 years for this product according to Article 8 (1) of Regulation (EC) 141/2000 for the same therapeutic indication. Hence, by defining „similarity“ the consultation deals with important questions around OMP market exclusivity as the term „similar“ defines the scope of OMP exclusivity. It might affect OMPs in the short term as the change of the definition might become effective as early as the beginning of the next year.
Article 3 (3) of the Commission Regulation 847/2000 (attached) already today provides a definition of ‘similar medicinal products’ and a number of examples defining what kind of products are to be regarded as similar for the purposes of the application of the incentives provided under Regulation 141/2000. However, this definition requires adaption to technical progress due to major developments in the field of biological medicines including advanced therapy medicinal products (ATMPs). The new definition will thus be especially important for ATMPs.
The proposal of the Commission provides for a removal of the term active substance and a new definition of similar active substance in Commission Regulation 847/2000. In the latter respect it proposes the following which is subject to the consultation:
1. Regarding Biological Medicinal products, it is proposed to update the examples to take into account new technological developments such as conjugation (conjugated coagulation factors), monoclonal antibody technology, cell-based medicinal products and gene therapy medicinal products (see lines 48 ff of the consultation document).
2. Regarding ATMPslines 99 ff of the consultation document provide the following:
„An active substance is not considered similar in cases of:
(aa) ATMPs for which principal molecular structural features cannot be fully defined and the similarity between two active substances needs to be assessed on the basis of biological and functional characteristics. In particular the following considerations apply in order to conclude whether two related cell-based medicinal products are not similar:
– there are differences in starting materials or the final composition of the product which have significant impact on the biological characteristics and/or activity relevant for the intended therapeutic effect of the product. The different source of the starting materials (e.g. as in the case of autologous ATMPs) is not sufficient to support a claim that two products are non-similar; or
– there are differences in the manufacturing technology having a significant impact on the biological characteristics and/or activity relevant for the intended therapeutic effect of the product.
(bb) Two gene therapy medicinal products when there are differences in the therapeutic sequence, viral vector, transfer system or regulatory sequences that significantly affect the biological characteristics and/or activity relevant for the intended therapeutic effect of the product. Minor differences in the therapeutic sequence without a significant impact on the intended therapeutic effect are not sufficient to support the claim that two gene therapy medicinal products are non-similar.
(cc) Genetically modified cells. The considerations under (aa) and (bb) apply.“
Companies relying on orphan exclusivity should assess and monitor the proposal of the Commission closely as at least some of the proposals are likely to be implemented soon after the consultation and might have a significant impact on exclusivity / business.