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Top 10 most read GaBI Online articles in 2015 Posted 15/01/2016

It has been a hectic year for biosimilars.  One of the most important milestones for biosimilars in 2015 was the finalization by the US Food and Drug Administration (FDA) of its regulatory guidelines for biosimilars. Other subjects of interest for biosimilars were the patent expiries of originator biologicals, clinical trials and extrapolation of indications. Biosimilars remain the hot topic for GaBI Online during 2015 and, in fact, all 10 of the most read articles concern biosimilars.

So what were the most viewed stories in GaBI Online during 2015? To ensure that none of GaBI Online’s readers missed out on what happened in 2015, below is a list of the top 10 most read articles in 2015. Follow the links in the titles of each article to find out more …

From this ‘most read’ articles overview, guidelines once again top the list, with the FDA’s finalization of its biosimilars guidelines coming in at the first position. Patent expiries of originator biologicals was also popular, coming a close second. Clinical trials for adalimumab biosimilars took the 4th and 5th positions.

Top 10 most read GaBI Online article (title and link*)

FDA finalizes biosimilars guidelines

Biologicals patent expiries

Cost of filgrastim biosimilars compared to originator filgrastim

Pivotal clinical trials for adalimumab biosimilars

Clinical trials for adalimumab biosimilars

Another infliximab switching trial started

Extrapolation of indications in biosimilars: infliximab

FDA calls for comment on biosimilars interchangeability

What happened in biosimilars during 2014

EMA recommends approval of etanercept biosimilar

*arranged in top 10 order with the most read article listed first


Top five most read articles relating to 'generics' (title and link**)

Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world

FDA evaluation of excipients in generics

Safety monitoring of drug interchangeability

FDA wants generics to be physically same as originators

Irish doctors’ attitudes towards generics

**arranged in top 5 order with the most read article listed first

During 2015 the European Medicines Agency (EMA) approved an etanercept biosimilar (Benepali), bringing the total number of biosimilars approved in the European Union to 20.

There are ongoing concerns from the medical community about switching biosimilars and about extrapolation of indications for biosimilars. These topics hit the top 10 ‘most read’ articles at the 6th and 7th positions, respectively. 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. EMA justifies its decision on extrapolation of infliximab based on the totality of evidence, which the agency says ‘indicated similar efficacy and safety of the biosimilar and the reference product in all therapeutic indications of infliximab’. On the subject of extrapolation for biosimilars, GaBI Journal has published three full papers during 2015 [1-3].

In light of ongoing austerity measures in many countries, an article comparing the cost of a biosimilar to its originator made it into the top 10 (3rd position). The study of the cost of filgrastim biosimilars (Tevagrastim and Zarzio) compared to originator filgrastim (Neupogen), and found that the total cost of treatment with Zarzio for one patient was the same as the cost of just one day of therapy with the originator.

On the subject of generics, proposals to lessen the shortage of essential cancer drugs (1st position) was the most read article for GaBI Online readers. Other topics of interest included the FDA evaluation of excipients in generics (2nd position) and safety monitoring of drug interchangeability (3rd position).

FDA’s efforts to make generics physically the same as originators (4th position) and Irish doctors’ attitudes towards generics (5th position); were also subjects of interest for readers in 2015.

Editor’s comment
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1.  Gerrard TL, Johnston G, Gaugh DR. Biosimilars: extrapolation of clinical use to other indications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(3):118-24. doi: 10.5639/gabij.2015.0403.027
2.  Derbyshire M. European biosimilars conference highlights extrapolation as key issue. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(3):149. doi: 10.5639/gabij.2015.0403.032
3.  Perks D. Supporting biosimilarity and extrapolation. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):180-3. doi: 10.5639/gabij.2015.0404.041

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