European Union: European Commission's Update Of Guideline On Duplicate Marketing Authorizations To Cover Biosimilars

Last Updated: 31 May 2018
Article by Geneviève Michaux and Luca Salernitano

On May 18, 2018, the European Commission ("Commission") launched a public consultation on "Duplicate Marketing Authorisation for Biological Medicinal Products" ("Consultation") in relation to updating its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicate MAs1"). The Commission wants to learn about the potential impact of duplicate marketing authorizations ("MAs") for "friendly" biosimilars, i.e., biosimilars developed by the innovators of the reference biological medicinal products. Comments are due by September 10, 2018.

Article 82(1) of Regulation 726/2004 expressly prohibited more than one MA for centrally authorized medicinal products, with two exceptions: (i) when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to healthcare professionals and/or patients ("public health") or (ii) for co-marketing. The prohibition of duplicate MAs and its exceptions apply to both chemical and biological medicinal products. The Commission is entrusted with applying the exceptions and authorizing duplicate MAs. The Note on Duplicate MAs concerns the application of Article 82(1) – see below.

The Note on Duplicate MAs gives friendly generics as an example of the public health exception. While friendly biosimilars should logically benefit from this exception as well, the Commission seems to have found that they should not because they may not increase the availability of medicinal products. If this finding is confirmed by the public consultation, obtaining duplicate MAs for friendly biosimilars would be more difficult than for friendly generics.

Article 82(1) of Regulation 726/2004

The objective of the centralized marketing authorization procedure is to have, for each medicinal product, one authorization and one name valid throughout the European Union. Article 82(1), first indent of Regulation 726/2004, thus limits to one the number of MAs that may be granted to medicinal products authorized through the centralized marketing authorization procedure.

The second indent, however, empowers the Commission to authorize more than one MA for a specific medicinal product "when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons."

Commission's Note on Duplicate Marketing Authorizations

For a long time, companies were basically left without guidance with regard to duplicate MAs. A few explanations had been given by the European Medicines Agency on the procedure to follow for requesting the Commission's authorization, but the criteria for obtaining such authorization remained unclear. The Commission was deciding on a case-by-case basis, and the grounds for allowing or refusing duplicate MAs were not publicly disclosed. On March 30, 2010, the Commission finally issued the Note on Duplicate MAs, which it updated about one year later.

Basic Principles and Conditions. Before defining the scope of application of Article 82(1) and detailing the authorization criteria, the Commission "sets the scene" by stressing the basic principles, i.e., (i) assessment of each request on a case-by-case basis, taking into account the factual circumstances of each case; (ii) restrictive interpretation of Article 82(1), second indent, because it constitutes an exception from the general rule of a single MA per medicinal product and per MA holder; and (iii) importance of the objectives of preserving public health and harmonizing centrally authorized products.

Scope of Application – Same Medicinal Product and Same Applicant. Article 82(1), second indent, only concerns an MA application ("MAA") submitted by an applicant regarding a medicinal product for which he was already granted an MA under the centralized procedure. This provision thus concerns a "same medicinal product" (material scope) and a "same applicant" (personal scope).

"Same Medicinal Product" – For determining whether the medicinal product is the "same," the Commission refers to:

  • its 1998 Communication on the Community marketing authorization procedures for medicinal products:2 any medicinal products with the same qualitative and quantitative composition in active substance (i.e., the same strength) and the same pharmaceutical form are to be considered as the same relevant product; and
  • Article 10(2)(b) of Directive 2001/83/CE: the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are to be considered to be the same active substance unless they differ significantly in properties with regard to safety and/or efficacy.

This means that an MAA for the following medicinal products does not require a prior Commission authorization under Article 82(1): a medicinal product with a different active substance; a medicinal product with a different salt of an approved active substance that differs significantly in properties regarding safety or efficacy; a medicinal product with different excipients resulting in significant differences with regard to safety or efficacy; or a medicinal product with a different manufacturer or manufacturing site resulting in its characteristics (notably in the case of biological products) leading to significant differences regarding safety or efficacy.

On the other hand, a duplicate MA for a different therapeutic indication requires a prior Commission authorization even in the case of an orphan indication for a medicinal product that is not orphan (i.e., in cases where a separate MA is mandatory). So also do MAAs for generic medicinal products, hybrid medicinal products or "informed consent" medicinal products. The key criterion is whether both MAAs relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

A duplicate MA may contain less therapeutic indications or pharmaceutical forms than the original MA when this is necessary to market the product in EU member states where a specific indication or pharmaceutical form is protected by patent law. However, the applicant must commit to extend the indication(s)/pharmaceutical form(s) of the duplicate MA or to withdraw the duplicate MA once the remaining patent protection expires, and the commitment letter should be provided with the MAA dossier. The harmonization of summary of product characteristics ("SmPCs") across the European Union being one of the basic pillars of the centralized procedure, applicants of duplicate MAs should not market two products with different indications/strengths/pharmaceutical forms in the same country.

"Same applicant" – For determining whether an applicant is the same, the Commission applies again the 1998 Communication on the Community marketing authorization procedures for medicinal products, which defines "same entity" as a company that belongs to the same group of companies or as a company that has entered into a license agreement or has otherwise agreed to the marketing of the medicinal product.

By way of examples, the Commission stresses that Article 82(1) does not apply where an applicant is an independent company that entered into a license agreement, purchase agreement or data agreement with the MA holder of the product but not for the placing of that product on the market.

Criteria for Duplicate MA. Article 82(1) provides for a derogation from the general rule of a single MA under two limited circumstances: public health or co-marketing.

Public Health – The Commission considers that arguments that are linked to public health but not to the availability of the product cannot be considered. Moreover, having more than one MA for the same product cannot, per se, be considered to increase availability.

The Note on Duplicate MAs gave two examples that both concern generics:

  • According to the Commission, the most common case in which a duplicate is justified on public health grounds is when a therapeutic indication or pharmaceutical form in the SmPC of the original MA is patent protected in one or more member states. The second example is the introduction of the first friendly generic product, as the first entry of a generic to the market usually increases accessibility. Any subsequent MAA of the innovator would need to be justified by further arguments and could not be based solely on the fact that the second MA for the same product concerns a generic. The Note on Duplicate MA does not indicate whether the justification holds in cases where the "friendly generic" is not the first generic on the market or whether the MAA for the friendly generic must be based on Article 10 rather than Article 10(3) or Article 10(c).

On the other hand, neither pricing and reimbursement considerations nor classification (prescription/non-prescription) considerations nor considerations based on national legislation deemed incompatible with EC law (e.g., names) are considered as relevant.

Co-Marketing – Co-marketing refers to an agreement between two parties to commercialize a specific medical product under different trademarks. Evidence of the co-marketing (contract or letter of agreement between the companies) must be provided to the Commission.

The Commission indicates that co-marketing requires the existence of two parties so that a request for a duplicate MA cannot be accepted when the two marketing entities belong to the same company group or if the co-marketing partners are already co-marketing (together) the product in the European Union. This exclusion, however, has no legal basis. Article 82(1) being only triggered by an MAA by the same company, and co-marketing being an express ground for parallel MAs, co-marketing should logically be accepted intra-group.

Co-marketing can be limited to one or more member states or cover the entire European Union, but it must not lead to partition of the internal market.

Update to the Note on Duplicate MA – Biosimilars as "First Generics"

The rules on duplicate MA also apply to biological medicinal products. The Commission, however, has identified potential issues related to the granting of a duplicate MA for a "first biosimilar." With regard to biological medicines, a duplicate MA may, but does not always, improve the availability of a specific medicinal product due to the potential impact of the friendly biosimilar on the biosimilar market (including anticompetitive effects) and on the number of treatment options for patients. Accordingly, the Commission wants to gain knowledge on this potential impact directly from the stakeholders.

As a side comment, we note that the Commission expressly adds that a request for authorization of a duplicate MAA "need[s] to be properly substantiated and based on sound evidence."

Stakeholders have until September 10, 2018 to submit their comments to the Commission. Until then, requests for duplicate MAs for biologicals will be assessed on a case-by-case basis, taking into account the evidence provided by the applicant company.


The Commission does not expect comments other than information on the potential impact of a first biosimilar on the availability of the biological medicinal product and number of treatment options. Yet, other comments can always be made if they are relevant.

The Commission allegedly adopted the Note on Duplicate MA "in order to ensure a smooth application of Article 82(1) of the Regulation and to create more transparency and predictability for the stakeholders concerned."

Three modifications to the updated Note on Duplicate MA can be suggested that would contribute to transparency and predictability.

First, the updated wording proposed by the Commission does not provide examples of situations where a friendly biosimilar does/does not increase the availability of the biological product. Such examples however would be very useful for transparency and predictability purposes.

Second, a section on the authorization procedure could be added in the Note on Duplicate MAs.

However, no guideline or the like has been adopted with regard to the authorization procedure. Companies know that they have to obtain the Commission's authorization before submitting the MAA dossier for a duplicate MA to the EMA, but they do not know to whom send the request, how long it takes to obtain such a decision, etc.

Furthermore, the Commission's authorizations are not publicly available, which means that companies cannot determine the justifications that have been accepted or rejected by the Commission for authorizing a duplicate MA. Publication of the Commission's reasoned decisions would also increase transparency and predictability.


1. latest_news/2011_09_duplicates_note_upd_01.pdf

2. 1998 OJ C229/4.

Originally published 30 May 2018

Visit us at

Mayer Brown is a global legal services provider comprising legal practices that are separate entities (the "Mayer Brown Practices"). The Mayer Brown Practices are: Mayer Brown LLP and Mayer Brown Europe – Brussels LLP, both limited liability partnerships established in Illinois USA; Mayer Brown International LLP, a limited liability partnership incorporated in England and Wales (authorized and regulated by the Solicitors Regulation Authority and registered in England and Wales number OC 303359); Mayer Brown, a SELAS established in France; Mayer Brown JSM, a Hong Kong partnership and its associated entities in Asia; and Tauil & Chequer Advogados, a Brazilian law partnership with which Mayer Brown is associated. "Mayer Brown" and the Mayer Brown logo are the trademarks of the Mayer Brown Practices in their respective jurisdictions.

© Copyright 2018. The Mayer Brown Practices. All rights reserved.

This Mayer Brown article provides information and comments on legal issues and developments of interest. The foregoing is not a comprehensive treatment of the subject matter covered and is not intended to provide legal advice. Readers should seek specific legal advice before taking any action with respect to the matters discussed herein.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions