2014 was once again a busy year for biosimilars, ranging from revision of regulatory guidelines to naming and extrapolation. Biosimilars remain the hot topic for GaBI Online during 2014 and, in fact, all 10 of the most read articles concern biosimilars.
So what were the most viewed stories in GaBI Online during 2014? To ensure that none of GaBI Online’s readers missed out on what happened in 2014, below is a list of the top 10 most read articles in 2014. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, guidelines for biosimilars stand out as the most read topic in 2014 (1st, 2nd, 7th and 10th positions). The US Food and Drug Administration (FDA) released further biosimilars guidance explaining how to use clinical pharmacology data to show biosimilarity to a reference product. During 2014 the European Medicines Agency (EMA) also revised its overarching biosimilars guideline, as well as its biosimilars quality guideline. EMA’s basic principle of establishing biosimilarity, not clinical benefit, was also discussed in the context of the agency’s monoclonal antibody guideline.
The somewhat contentious issue of substitution of biosimilars was highlighted by the passing of legislation in France which would allow substitution of biosimilars by pharmacists (3rd position).
How to name biologicals and biosimilars was also under discussion once again during 2014 (4th position), with the majority of EU Member States agreeing that biosimilars should have the same International Nonproprietary Name (INN) as their reference biological. On the subject of naming biosimilars, GaBI Journal has published a full paper by Dr Richard O Dolinar and Mr Michael S Reilly [1].
There are ongoing concerns from the medical community about extrapolation of indications for biosimilars; this topic hit the top 10 ‘most read’ articles twice (5th and 8th positions). Such distrust in biosimilars is believed could be a cause of the lower than expected uptake for biosimilars in Europe, which is especially the case in extrapolated indications. While the fact that post-marketing studies have confirmed the efficacy and safety of filgrastim biosimilars in the approved indications including the mobilization of stem cells in healthy donors justifies EMA’s decision on extrapolation.
The future is looking bright for forthcoming biosimilar launches, with publicly-disclosed biosimilars development projects increasing by over 40% during 2014 (6th position). The most popular biosimilar targets include monoclonal antibodies and Amgen’s arthritis blockbuster Enbrel (etanercept).
On the subject of generics, the impact of delisting angiotensin receptor blockers (ARBs) in Denmark (1st position) was the most interesting article for GaBI Online readers. Other topics of interest included the confusion that exists in Brazil over generics (2nd position) and generics applications under review by EMA (3rd position). Regarding reducing costs through the use of generics, GaBI Journal has published a full paper by Dr Brian Godman and co-authors [2].
Generic atypical antipsychotic drugs in Belgium (4th position) and companies failing to pay US generics fees (5th positions), were also subjects of interest for readers in 2014.
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References
1. Dolinar RO, Reilly MS. Biosimilars naming, label transparency and authority of choice – survey findings among European physicians. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(2):58-62. doi:10.5639/gabij.2014.0302.018
2. Godman B, et al. European payer initiatives to reduce prescribing costs through use of generics. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):22-7. doi:10.5639/gabij.2012.0101.007
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