Last update: 12 February 2014
The past year has been a busy one for the biosimilars’ industry. One of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar infliximab [Remsima/Inflectra] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4]. In fact, in Europe, the European Medicines Agency (EMA) has been busy during 2013 approving five biosimilars [5, 6].
The hottest debated topic during 2013 has been the issue of how to name biosimilars at both the international and national level. Stakeholders from both sides have sent Citizen Petitions to the US Food and Drug Agency (FDA) asking for biosimilars to have either unique or identical names to their reference products depending on different stakeholders’ point of view [7, 8]. During the October 2013 World Health Organization’s meeting on INNs, pharmaceuticals stakeholders, including the European Generic medicines Association (EGA), called for biosimilars to be assigned the same INN as their reference biologicals. While others, including the Alliance for Safe Biologic Medicines (ASBM), called for the use of distinct non-propriety names for biological medicines [9].
Another significant development in the US during 2013 was the passing or rejection of state legislation allowing the substitution of biosimilars, but with, in many cases, restrictions requiring physician and/or patient notification, as well as record-keeping [10, 11].
EMA has also drafted new guidelines during the last year. The agency issued a draft concept paper on comparing quality in biologicals and biosimilars [12], and also held a workshop on its three draft revised overarching guidelines on biosimilars [13].
FDA introduced its biosimilars user fee programme during 2013 [14], and issued draft guidance for biosimilar meetings [15].
There have been numerous trials for candidate biosimilars started in 2013 and many companies also presented results of studies for their biosimilars, showing that the pipeline for biosimilars is both robust and increasing. Biosimilar deals have also been on the agenda again during 2013, proving that biosimilars are still seen as a profitable area for companies to move into.
Guidelines have also been a hot topic for 2013, with Colombia issuing a draft decree for the registration of biologicals, which includes similar biotherapeutic products in January 2013 [16]. Australia’s drug regulatory agency, Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website in July 2013, which included a section on naming conventions for biosimilars [17].
Meanwhile, India’s drug regulator, the Drugs Controller General of India (DCGI) granted marketing approval for the world’s first trastuzumab ‘similar biologic’ in November 2013 [18]. While India-based generics company Intas Pharmaceuticals launched its rituximab ‘similar biologic’ in India in May 2013 [19].
2013 has been a busy year for biosimilars, making the future look bright for 2014 in the biosimilars’ market.
Readers interested to learn more about the top developments in biosimilars during 2013 are invited to visit www.gabi-journal.net to view the full manuscript published in GaBI Journal:
Top developments in biosimilars during 2013
Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Related articles
Top developments in biosimilars during 2012
Top developments in biosimilars during 2011
References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – 2013 Q4 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q4
7. GaBI Online - Generics and Biosimilars Initiative. J&J adds its opinion to biosimilars naming debate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/J-J-adds-its-opinion-to-biosimilars-naming-debate
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars naming debate intensifies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-naming-debate-intensifies
9. GaBI Online - Generics and Biosimilars Initiative. Calls for biosimilars to have same INN at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Calls-for-biosimilars-to-have-same-INN-at-WHO-meeting
10. GaBI Online - Generics and Biosimilars Initiative. Sharing biosimilars substitution information with patients critical [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/Research/Sharing-biosimilars-substitution-information-with-patients-critical
11. GaBI Online - Generics and Biosimilars Initiative. US state legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Policies-Legislation/US-state-legislation-on-biosimilars-substitution
12. GaBI Online - Generics and Biosimilars Initiative. EMA issues draft concept paper on comparing quality in biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Guidelines/EMA-issues-draft-concept-paper-on-comparing-quality-in-biologicals-and-biosimilars
13. GaBI Online - Generics and Biosimilars Initiative. EGA commends EMA workshop on biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/EGA-commends-EMA-workshop-on-biosimilars-guidelines
14. GaBI Online - Generics and Biosimilars Initiative. FDA extends biosimilars deadlines due to US shutdown [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/FDA-extends-biosimilars-deadlines-due-to-US-shutdown
15. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for biosimilar meetings [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-biosimilar-meetings
16. GaBI Online - Generics and Biosimilars Initiative. Colombia issues draft decree for registration of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals
17. GaBI Online - Generics and Biosimilars Initiative. Naming requirements in Australian biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Guidelines/Naming-requirements-in-Australian-biosimilars-guidance
18. GaBI Online - Generics and Biosimilars Initiative. Indian regulator approves first trastuzumab ‘similar biologic’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Indian-regulator-approves-first-trastuzumab-similar-biologic
19. GaBI Online - Generics and Biosimilars Initiative. Intas launches rituximab ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Intas-launches-rituximab-similar-biologic-in-India
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