2013 was a busy year with lots of developments in the biosimilars arena, ranging from revision of regulatory guidelines to new biosimilar approvals. Biosimilars remain the hot topic of the year for GaBI Online during 2013 and in fact all 10 of the most read articles concern biosimilars.
So what were the most viewed stories in GaBI Online during 2013? To ensure that none of GaBI Online’s readers missed out on what happened in 2013, below is a list of the top 10 most read articles in 2013. Follow the links in the titles of each article to find out more…
From this ‘most read’ articles overview, monoclonal antibodies stand out as the newest and most read topic for 2013 (1st, 3rd, 4th and 5th positions). The landmark decision by the European Medicines Agency (EMA) to approve its first monoclonal antibody biosimilar proved that the biosimilar concept can be successfully applied to such complex molecules as monoclonal antibodies. However, issues of possible immunogenicity produced by monoclonal antibodies remain; for this topic, GaBI Journal has published a full paper by Dr Vera Brinks [4].
The INNs for biosimilars was also discussed at an international level during 2013 (2nd position) and the European Commission Directive 2012/52/EU lays down measures to identify biological products by brand name (7th position). The issue of whether biosimilars should have INNs identical to their reference products or be given a unique INN remains on the agenda in 2014.
Once again the topic of the European uptake of biosimilars, highlighted by the situation in Italy (6th position), has made it into the top 10 most read list. Despite there being three off-patent biologicals (epoetin, filgrastim, somatropin) in Italy for which biosimilars are available, biosimilars manufacturers are failing to compete in the Italian market. For this topic, GaBI Journal has published a full paper by Mr Alessandro Curto and co-authors [1].
The lack of publicly available data on the efficacy, extrapolation and interchangeability of biosimilars was also highlighted during 2013 (8th position). This was pointed to as a reason for physicians having concerns about the use of biosimilars. Some of these concerns were discussed by members and experts of the Working Party on Similar Biologic Medicinal Products of EMA.
In June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month consultation period (9th position). To date no updated guideline has been released by EMA.
Finally, EMA Head of Biologicals Dr Peter Richardson discussed a new report published by the European Commission about biosimilars in Europe in general (10th position). Dr Richardson reiterated that biosimilars have the same safety and efficacy as originator biologicals and that to date there have been no safety issues reported to EMA concerning biosimilars approved in Europe.
On the subject of generics patent expiries (1st position) was of most interest to GaBI Online readers. Other topics of interest included anti-competitive practices by originator companies (2nd position) and innovation in the generics industry (3rd position) [2].
Pharmaceutical expenditure, and how generics contributed to this, was another subject of interest for readers in 2013 (4th and 5th positions). For this topic, GaBI Journal has published a full paper by Dr Sabine Vogler and co-authors [3].
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References
1. Curto A, Van de Vooren K, Garattini, L, Lo Muto R, Duranti S. Regional tenders on biosimilars in Italy: potentially competitive? Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):123-9. doi:10.5639/gabij.2013.0203.036
2. Barei F, Le Pen C, Simoens S. The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1):13-9. doi:10.5639/gabij.2013.0201.011
3. Vogler S, Zimmermann N, Habl C. Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):178-87. doi:10.5639/gabij.2013.0204.051
4. Brinks V. Immunogenicity of biosimilar monoclonal antibodies. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):88-93. doi:10.5639/gabij.2013.0204.052
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