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Biosimilars applications under review by EMA – December 2016

Biosimilars/General | Posted 13/01/2017 6 Post your comment

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to EMA [1].

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 2 December 2016, the agency is reviewing 16 biosimilar applications. One application is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2]. Two applications are for leukaemia drug rituximab. EMA’s CHMP gave a positive opinion for Celltrion’s rituximab biosimilar Truxima (CT-P10) on 15 December 2016 [3].

The other applications are four for arthritis treatment adalimumab, two for arthritis treatment etanercept, one for fast acting insulin analog insulin lispro, three for neutropenia treatment pegfilgrastim and three for breast cancer treatment trastuzumab, for which there are currently no biosimilars available on the European market [4], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name	Therapeutic area	Number of applications	Originator product(s)	Originator company
Adalimumab	Immunosuppressant	4	Humira	AbbVie
Etanercept	Immunosuppressant	2	Enbrel	Amgen
Insulin glargine	Diabetes	1	Lantus	Sanofi-Aventis
Insulin lispro	Diabetes	1	Humalog	Eli Lilly
Pegfilgrastim	Immunostimulant	3	Neulasta	Amgen
Rituximab	Antineoplastic medicine (anti-cancer)	2	MabThera/Rituxan	Roche
Trastuzumab	Antineoplastic medicine (anti-cancer)	3	Herceptin	Roche
Total		16
*Data collected on 12 January 2017 Source: EMA

On 1 April 2016, EMA’s CHMP announced that it had recommended approval of the infliximab biosimilar Flixabi (SB2), from Samsung Bioepis [5]. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [6].

The patents on the originator product Remicade (infliximab) expired in Europe in February 2015 and will expire in the US in November 2018 [7].

Since the last report entitled Biosimilars applications under review by EMA – August 2016 by GaBI Online, the CHMP has announced that applications for marketing authorizations for the pegfilgrastim biosimilars Cavoley and Efgratin have been withdrawn. The CHMP also gave a positive opinion for Celltrion’s rituximab biosimilar Truxima (CT-P10) [3].

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13].
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
6. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries

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Source: EMA

Comments (6)

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Posted 27/04/2017 by Louis B, GaBI Online Editorial Office

Response to ‘Regulatory status of Lifmior’

Thank you for your comment on 26/4/2017. We do not have information on whether or not “Lifmior is expressly considered as a 'duplicate'” of Enbrel. We also only have the information from the EMA website.
Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online.
Best Regards, Louis

Posted 26/04/2017 by D.M.

Regulatory status of Lifmior

Thank you for your comment and your input! In fact, I read in another press article that Lifmior is a duplicate of Enbrel. But as you mentioned, it is not expressly indicated in the summary of the EPAR that this medicine has been evaluated on the legal basis of article 82(1), even though on page 9 we can read that this medicinal product is a 'duplicate' of Enbrel. I think that it is a little bit confusing and I would be glad to know if Lifmior is expressly considered as a 'duplicate' or not. If you have further information on this point, please do not hesitate to share it. Thank you!

Posted 25/04/2017 by Paul Declerck

Regulatory status of Lifmior

The wording 'duplicate' used in my initial comment may not have been optimal in the regulatory context. Scientifically the product is "identical" to that of Enbrel.

The summary of the EPAR mentions: “Lifmior is identical to Enbrel, which has been authorised in the EU since 3 February 2000. It contains the active substance etanercept.”

Page 4 of the EPAR mentions: “The applicant Pfizer Limited submitted on 21 July 2016 an application for a marketing authorisation to the European Medicines Agency (EMA) for LIFMIOR, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004 – ‘Generic of a Centrally authorised product’. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 28 January 2016.
The application concerns a generic medicinal product as defined in Article 10(1) of Directive 2001/83/EC and refers to a reference product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Article 8(3) of Directive 2001/83/EC.”

So regulatory wise it has the status of a "generic" (which is obviously somehow a misnomer or at least confusing in the context of biologicals).

Posted 24/04/2017 by D. M.

Lifmior

How can you affirm that Lifmior is a duplicate ? I read the MA decision from the EC and the assessment report from the CHMP (EMA), but there is no express reference to Article 82(1) of Regulation 726/2004. Is it possible to have an implicit duplicate authorisation ? Thank you in advance for your help !