CHMP and Rapporteurs JAR template on assessment of similarity
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Committee for Medicinal Products for Human Use (CHMP)
<Updated> <Rapporteurs' Joint ><CHMP>Assessment
Report <CHMP LOQ>for <Product> on similarity with
<name of authorised orphan product>
International Nonproprietary Name: <INN> / Common Name
Procedure No. EMEA/H/C/XXX
Rapporteur:
Co-Rapporteur:
7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8613
E-mail info@ema.europa.eu Website www.ema.europa.eu
An agency of the European Union
Table of contents
5. <Assessment on the responses to the list of questions> ......................... 9
6. <Final Conclusion and recommendation> ................................................ 9
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Administrative information
Type of information Names
Name of the medicinal product:
INN/Common name:
Applicant:
Therapeutic indication(s):
Pharmaco-therapeutic group
(ATC Code):
Pharmaceutical form(s) and strength(s):
Rapporteur’s contact person:
Co-Rapporteur’s contact person:
EMA PTX-Q:
Names of the Rapporteur´s member and assessors:
Names of the Co-Rapporteur´s member and assessors:
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1. Introduction
On <date>, <applicant/MAH> filed an application for <an initial marketing authorisation><an extension application> <for an extension of an indication> of the medicinal product <name of product> using the centralised procedure for the following indication<s>:
<list of indication(s) applied>
<name of product> (INN/common name) is designated as an orphan medicinal product for the following condition:
<state the designated orphan condition>
Currently authorised orphan medicinal products in <designated orphan condition>
1.
<name of the authorised orphan product>, (INN/ common name of the authorised orphan product), <applicant/MAH>
2.
<name of authorised orphan product>, (INN/ common name of authorised orphan product),
<applicant/ MAH>
3.
Potential conflict with authorised orphan-designated medicinal products protected by market exclusivity in the EU
According to Article 8(1) of Regulation (EC) No 141/2000, where a marketing authorisation in respect of an orphan medicinal product is granted, the Union and the Member States shall not, for a period of
10 years, without prejudice to intellectual property law or any other provision of European Union law, 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.
In accordance with the Commission Communication on orphan Medicinal Products (2003/C 178/02, 29
July 2003) it is the responsibility of the CHMP to give an opinion on the similarity of products submitted via the centralised procedure, vis-à-vis authorised orphan medicinal products. This Assessment Report will address the potential similarity (assessment of molecular structural similarity) between <name of product> (INN/common name) and <name of authorised orphan product> (INN of authorised orphan product) for the treatment of <indication>, taking into account the Commission Regulation (EC) No
847/2000 and the Guideline on aspects of the application of Article 8(1) and 8(3) of Regulation (EC)
No. 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity (2008/C
242/08).
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<Product> on similarity with <name of authorised orphan product>
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2. Similarity assessment
Table 1 Summary table of medicinal product under evaluation and authorised orphan medicinal product(s):
Medicinal product under evaluation Authorised orphan medicinal product
<Name of product>
<active substance / INN / common name>
<IUPAC:>
<Therapeutic indication>
<mechanism of action>
<Structure>
<Name of product>
<active substance / INN / common name>
<IUPAC:>
<Therapeutic indication>
<mechanism of action>
<Structure>
<Other important quality information:>
[e.g molecular formula; relative molecular mass, functional groups; molecular formula; type of atoms; etc. ]
<Other important quality information:>
[e.g molecular formula; relative molecular mass, functional groups; molecular formula; type of atoms; etc. ]
<class of biological product>
[particularly if mentioned in the legislation e.g. article 3.3(c)2 of Regulation 847/2000]
<class of biological product>
[particularly if mentioned in the legislation e.g. article 3.3(c)2 of Regulation 847/2000]
<Name of product>
<active substance / INN / common name>
<IUPAC:>
<Therapeutic indication>
<mechanism of action>
<Structure>
<Other important quality information:>
[e.g molecular formula; relative molecular mass, functional groups; molecular formula; type of atoms; etc. ]
<class of biological product>
[particularly if mentioned in the legislation e.g. article 3.3(c)2
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<Product> on similarity with <name of authorised orphan product>
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of Regulation 847/2000]
<Name of product>
<active substance / INN / common name>
<IUPAC:>
<mechanism of action>
<Therapeutic indication>
<Structure>
<Other important quality information:>
[e.g molecular formula; relative molecular mass, functional groups; molecular formula; type of atoms; etc. ]
<class of biological product>
[particularly if mentioned in the legislation e.g. article 3.3(c)2 of Regulation 847/2000]
2.1. Therapeutic Indication
Applicant´s position
[The applicant’s position should be summarised.]
<Rapporteurs’> <CHMP> position
[The Rapporteur/CHMP should discuss the arguments provided by the
Applicant. If the applicant claims to cover a different therapeutic indication, which is a different subset of the designated orphan condition for the authorised orphan medicinal product, the applicant will have to establish that the difference between the two subsets is clinically meaningful. If there is an overlap of the target populations of two allegedly different therapeutic indications, the second applicant would have to provide an estimate of its extent. The extent of the overlap will be a relevant factor for the Rapporteur/CHMP to establish whether the claim for two different therapeutic indications can be upheld.
For the purpose of similarity, CHMP does not look at the orphan condition but at the therapeutic indication that come with in.]
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2.2. Mechanism of action
Applicant´s position
[The applicant’s position should be summarised]
<Rapporteurs’> <CHMP> position
The Rapporteur/CHMP should discuss the arguments provided by the
Applicant. Please note that two active substances may only be considered to have the same mechanism of action, provided that both share the same pharmacological target (receptor, enzyme, channel, carrier or an intracellular coupling process) and pharmacodynamics effect (primary pharmacodynamics effect of the active substance).
2.3. Molecular Structure
Applicant´s position
[The applicant position should be summarised]
<Rapporteurs’ position> <CHMP position><The PTX-Q with the Rapporteurs’ assessors should progressively update this document>
[The Rapporteurs should describe the chemical, physico-chemicalbiological structure of the active substance(s) under evaluation with the orphan drugs authorised. Furthermore, the rapporteurs/CHMP should highlight the main differences between the orphan drug(s) already approved and the active substance under evaluation in terms of chemica, physico-chemical-biological features. In the final conclusion the rapporteurs/CHMP should reflect the reason why the two active substances are similar or not similar in the context of orphan medicinal product legislation i.e. they share or do not share the same principal molecular features (but not necessarily all of the same molecular features).
For chemical substances similarity coefficients using different fingerprints might be used in the evaluation of the similarity of the active substances (chemicals). The values of similarity coefficients using different fingerprints should be discussed. The differences between the similarity coefficients provided by the applicant and the obtained by the rapporteurs should be discussed.]
< Table 2: Supportive Information (Computated Quantitative Similarity Calculations)>
Fingerprints Tanimoto Cosine
A
B
C
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Euclidean <N = other similarity coefficients >
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D
[For biological active substances, examples of similar active biological substances in the context of orphan medicinal products is given in article 3.3(c)2 of Regulation 847/2000.]
3. Conclusion
[The table below should be filled in.]
The position of the <rapporteurs’> <CHMP> on similarity with authorised products is summarised in the table below:
Table 3: Similarity assessment of ,<name of product> with authorised orphan medicinal products
Medicinal product under evaluation
Authorised Orphan medicinal product
Final conclusion
<(Name of product>
<active substance / INN / common name>
<Name of product>
<active substance / INN / common name>
<Name of product>
<active substance / INN / common name>
<Name of product>
<active substance / INN / common name>
<SIMILAR><NOT
SIMILAR> based on
<therapeutic indication>< mechanism of action>
<principal molecular structure>
<SIMILAR><NOT
SIMILAR> based on
<therapeutic indication>< mechanism of action>
<principal molecular structure>
<SIMILAR><NOT
SIMILAR> based on
<therapeutic indication>< mechanism of action>
<principal molecular structure>
[repeat paragraphs as applicable]
<Having considered the arguments presented by the applicant of <name of product>, it is concluded that the <therapeutic indication> <and> <mechanism of action> <and> <molecular structure> of
<name of product> and <name of authorised orphan product(s)> are considered similar in the context of orphan medicinal products.>
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<With reference to Article 8 of Regulation (EC) No 141/2000, <name of product> is considered similar
(as defined in Article 3 of Commission Regulation (EC) No. 847/2000) to <name of authorised orphan product>.>
[repeat paragraphs as applicable]
<Having considered the arguments presented by the applicant of <name of product>, it is concluded that the <therapeutic indication> <and> <mechanism of action> <and> <molecular structure, of
<name of product> and <name of authorised orphan product> are considered not similar in the context of orphan medicinal products.>
<As defined in Article 3 of Commission Regulation (EC) No 847/2000, <name of product> is not considered similar to <name of authorised orphan product>.>
<With reference to Article 8 of Regulation (EC) No 141/2000, <name of product> is considered not similar (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) to <name of authorised orphan product> with regard to <therapeutic indication(s)> <and><mechanism of action><and><molecular structure>.
<Therefore, with reference to article 8 of Regulation (EC) No. 141/2000, the existence of any market exclusivity for <name of authorised orphan product> in the treatment of <orphan designation>, does not prevent the granting of the marketing authorisation of <name of product>. This finding is without prejudice to the outcome of the scientific assessment of the marketing authorisation application.>
4.
<
List of questions>
5. <Assessment on the responses to the list of questions>
6. <Final conclusion>
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