One of the most important developments during 2012 was the progress made in the US biosimilars pathway. In February 2012, FDA issued three draft guidance documents on biosimilars to assist industry in developing such products in the US [1]. This was followed by a one-day public hearing held on 11 May 2012 to gather input from stakeholders on the draft guidances. At the meeting, stakeholders expressed their desire for FDA to harmonize with EMA’s guidances for biosimilars, which provide detailed guidance for biosimilars according to classes [2]. As yet, no final guidelines have been issued.

In Europe, EMA has once again been busy drafting new guidelines during the last year. The long-anticipated guideline for biosimilar monoclonal antibodies came into effect in December 2012, along with a guideline for immunogenicity assessment of monoclonal antibodies [3]. In the meantime, EMA also released a guideline to revise its overarching guideline on quality issues for biosimilars in May 2012. The guideline was open to comment from stakeholders until November 2012 [4]. EMA also released draft specific guidance for recombinant interferon beta biosimilars in January 2012 and for recombinant human insulin in December 2012. These draft guidelines were open for comments until May 2012 and June 2013 [5, 6].

EMA has also been busy promoting biosimilars outside of the pharmaceutical industry. In September 2012, the agency published a revised Questions and Answers document on biosimilar medicines aimed at patients and the general public [7].

Despite there still not being an established biosimilars pathway in the US, in October 2012 Sandoz, the generic drug division of Swiss drug giant Novartis, announced that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alpha (Amgen/Johnson & Johnson’s Epogen/Procrit). Sandoz is the only biosimilars manufacturer to have more than two biosimilars on the market and is set to be a market leader, with 8–10 molecules at various stages of development [8].

Reliance Life Sciences also started a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India [9]. While Teva Pharmaceutical Industries and South Korean electronics giant Samsung halted their biosimilar rituximab development, possibly due to changes in safety requirements in Europe and the US [10, 11].

Biosimilar approvals have been coming thick and fast during 2012. In July 2012, South Korean biotechnology company Celltrion announced that the Korean Food and Drug Administration had approved its first monoclonal antibody, Remsima (infliximab) [12]. The company is now awaiting EMA approval, and in fact EMA is currently reviewing eight biosimilar applications [13].

In June 2012, Finox Biotech announced that the company’s pivotal phase III study with Afolia, a biosimilar recombinant follicle stimulating hormone (r-FSH), in patients undergoing assisted reproduction technology, had met its primary end point [14]. This led to the Swiss-based company to submit a Marketing Authorisation Application for its biosimilar r-FSH to EMA on 30 October 2012 [15].

In November 2012, Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan [16].

Marvel LifeSciences (Marvel) announced in November 2012 that the company would be withdrawing its EMA authorization applications for its three biosimilar human insulins. Marvel stated that ‘the decision to withdraw is in order to have sufficient time to repeat and submit bioequivalence type-1 diabetes pharmacokinetic/pharmacodynamic data on each clamp study [pivotal pharmacodynamic study] in order to comply with the planned new insulin guideline’ from EMA [17].

Biosimilar deals have also been on the agenda again during 2012. Some notable deals made during 2012 include those of Merck KGaA and Dr Reddy’s to collaborate on biosimilar monoclonal antibodies [18] and Japanese digital camera maker Fujifilm Corporation (Fujifilm) and biotech firm Kyowa Hakko Kirin (Kyowa) [19]. More deals were made between AET BioTech, the biosimilars business of generics drugmaker AET (Alfred E Tiefenbacher) Group and Swiss-based biotech company BioXpress for a biosimilar version of the tumour necrosis factor (TNF) inhibitor monoclonal antibody adalimumab, as well that between Israeli glycoanalysis company ProCognia and Norway’s UniTargetingResearch for the production of biosimilars. Other agreements include those made between Oncobiologics and Boston Oncology, and US-based Pharmatech Associates and China-based Innovent Biologics [20].

Guidelines have also been a hot topic for 2012, with biosimilars’ guidelines being issued by India and Mexico [21, 22]. While, China, one of the largest pharmaceutical markets in the world, is also reportedly ready to issue biosimilars guidelines [23].

With the US slowly moving towards implementing practical guidance for their biosimilars pathway and further more specific guidelines emerging in Europe, the future looks bright for 2013 in the biosimilars’ market.

Related article

Top developments in biosimilars during 2011

References

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2.  GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances

3.  GaBI Online - Generics and Biosimilars Initiative. EMA finalises biosimilar monoclonal antibody guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/EMA-finalises-biosimilar-monoclonal-antibody-guidelines

4.  GaBI Online - Generics and Biosimilars Initiative. EMA revised guideline on quality of biosimilar medicines open for comments [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/EMA-revised-guideline-on-quality-of-biosimilar-medicines-open-for-comments

5.  GaBI Online - Generics and Biosimilars Initiative. EMA publishes draft biosimilar guideline for interferon beta [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/EMA-publishes-draft-biosimilar-guideline-for-interferon-beta

6.  GaBI Online - Generics and Biosimilars Initiative. EMA publishes draft guideline for biosimilar human insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/EMA-publishes-draft-guideline-for-biosimilar-human-insulin

7.  GaBI Online - Generics and Biosimilars Initiative. EMA publishes revised biosimilar Q&A document for patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/EMA-publishes-revised-biosimilar-Q-A-document-for-patients

8.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III US trial for biosimilar epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/Research/Sandoz-starts-phase-III-US-trial-for-biosimilar-epoetin-alfa

9.  GaBI Online - Generics and Biosimilars Initiative. Reliance Life Sciences starts ‘similar’ infliximab trial in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Reliance-Life-Sciences-starts-similar-infliximab-trial-in-India

10.  GaBI Online - Generics and Biosimilars Initiative. Teva halts phase III biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial

11.  GaBI Online - Generics and Biosimilars Initiative. Samsung halts biosimilar rituximab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Samsung-halts-biosimilar-rituximab-development

12.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

13.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – 2012 Q4 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2012-Q4

14.  GaBI Online - Generics and Biosimilars Initiative. Successful phase III trial of biosimilar r-FSH [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Successful-phase-III-trial-of-biosimilar-r-FSH

15.  GaBI Online - Generics and Biosimilars Initiative. Finox submits r-FSH biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Finox-submits-r-FSH-biosimilar-application-to-EMA

16.  GaBI Online - Generics and Biosimilars Initiative. Approval of first biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Approval-of-first-biosimilar-G-CSF-in-Japan

17.  GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications

18.  GaBI Online - Generics and Biosimilars Initiative. Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-and-Dr-Reddy-s-to-collaborate-on-biosimilar-mAbs

19.  GaBI Online - Generics and Biosimilars Initiative. Fujifilm and Kyowa launch biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Fujifilm-and-Kyowa-launch-biosimilars-joint-venture

20.  GaBI Online - Generics and Biosimilars Initiative. The latest biosimilars agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/The-latest-biosimilars-agreements

21.  GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/Indian-guidelines-for-similar-biologics

22.  GaBI Online - Generics and Biosimilars Initiative. Mexican guidelines for biocomparables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/Mexican-guidelines-for-biocomparables

23.  GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines

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