European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation

Regulatory NewsRegulatory News | 29 July 2016 |  By 

The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress.

Fifteen years after the implementation of the orphan legislation, the commission says it is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensuring timely access to medicinal products. 

In this context, the Commission has decided to launch a targeted review of Commission Regulation (EC) No 847/2000 on the concept of similarity, as well as to finalize the revision of the 2003 Communication on Regulation (EC) No 141/2000 on orphan medicinal products (2003/C 178/02), which will be replaced by a notice. 


The cornerstone of the orphan legislation is the idea of increased market exclusivity for medicines that address rare diseases. 

“When a marketing authorisation for an orphan medicinal product is granted, the Union and the Member States shall not for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation for the same therapeutic indication, in respect of a similar medicinal product,” the commission says.

The commission is now looking to rework Article 3 paragraph (3) of Commission Regulation 847/2000, which 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. 

“The definitions of Regulation 847/2000 require adaption to technical progress due to major developments in the field of biological medicines including advanced therapy medicinal products,” the consultation says.


Among the major changes is a proposal to remove the definition of active substance and re-define similar active substances with an eye toward taking into account the existence of ether and co-valent derivatives.

“The current definition of similar active substance raises numerous questions from stakeholders in relation to the meaning of the principal molecular structural features. Moreover, the examples to define what products are considered similar do not take into account the existence of ether and co-valent derivatives. Over the years, more orphan medicinal products have been developed and authorised. It is therefore crucial to bring certainty on the application of the concept of similarity taking into account new pharmaceutical developments. To this end, it is proposed to provide a definition of the principal molecular structural features, to add a reference to ether and to remove the reference to non-covalent derivatives of the original active substance to take into consideration the covalent and non-covalent derivatives,” the consultation says.

The commission is also seeking to update and revise the examples of biologic medicines contained in the legislation.

“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,” the commission adds. 

Stakeholders are invited to provide their views on the textual changes suggested to Article 3 of Commission Regulation (EC) No 847/2000. 



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