It has once again been a busy year for biosimilars. An important milestone for biosimilars in 2016 was the adoption by the European Medicines Agency (EMA) of new guidance on monitoring biologicals. While the US Food and Drug Administration (FDA) approvals of infliximab and adalimumab biosimilars were also important events in 2016. Other subjects of interest for biosimilars were the differences between biosimilars and reference biologicals, biosimilarity and switching biosimilars. Biosimilars remain the hot topic for GaBI Online during 2016.
So what were the most viewed stories in GaBI Online during 2016? To ensure that none of GaBI Online’s readers missed out on what happened in 2016, below is a list of the top 10 most read articles in 2016. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, differences between biosimilars and reference products topped the list, perhaps highlighting concerns over what possible differences between biosimilars and originator biologicals could mean for patients. This leads into traceability or pharmacovigilance, i.e. monitoring of biologicals, which came a close second. It is important that should there be a reaction to any biological that the source can be traced. According to EMA, ‘it is this fundamental complexity that creates the specific challenges for biologicals in pharmacovigilance’.
Biosimilarity and GaBI Online’s overview of what happened in biosimilars during 2015 were the next most popular topics in 2016, taking the 3rd and 4th positions. On the subject of biosimilarity, GaBI Journal has published three full papers during 2016 [1-3].
During 2016, EMA approved an etanercept biosimilar (Benepali) and an infliximab biosimilar (Flixabi). While EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on two teriparatide biosimilars (Movymia and Terrosa) and an insulin glargine biosimilar (Lusduna). These approvals bring the total number of biosimilars approved in the European Union to 24 .
Meanwhile, also during 2016, the US FDA approved an infliximab biosimilar [Inflectra (infliximab-dyyb)], an etanercept biosimilar [Erelzi (etanercept-szzs)] and an adalimumab biosimilar [Amjevita (adalimumab-atto)]. This brings the total number of biosimilars approved by FDA to four, along with a follow-on biological (insulin), which was also approved using an abbreviated process .
There are still ongoing concerns from the medical community about switching biosimilars. This is reflected by this topic hitting the top 10 ‘most read’ articles at the 6th, 7th and 10th positions. Such distrust in biosimilars is believed could be a cause of the lower than expected uptake for biosimilars in Europe, with concerns about the safety and efficacy of biosimilars dissuading many healthcare professionals from prescribing them. However, positive results from the NOR-SWITCH study, which found biosimilar infliximab to be not inferior to originator infliximab, are hoped could change such opinions on biosimilars. These results, along with positive recommendations on switching biosimilars from respected societies and bodies could help to increase prescribing of biosimilars. On the subject of switching biosimilars, GaBI Journal published an abstract in 2016 .
On the subject of generics, the applications under review by EMA (1st position) were the most interesting article for GaBI Online readers. Other topics of interest included generics in seizure control (2nd position) and the American Epilepsy Society (AES) position statement on substitution of generic anti-epileptics (3rd position). On the subject of substitution or interchangeability of generics, GaBI Journal has published two full papers during 2016 [7, 8].
How cost-effectiveness analysis can affect innovation when it comes to medicines (4th position) and how regulators can influence affordability (5th position), were also subjects of interest for readers in 2016, perhaps highlighting the increasing efforts by countries to reduce healthcare budgets. GaBI Journal has published two full papers during 2016 related to this subject [9, 10].
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Top 10 most read GaBI Online articles in 2015
Top 10 most read GaBI Online articles in 2014
1. Derbyshire M. Data requirements to demonstrate biosimilarity in the EU. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):182-4. doi:10.5639/gabij.2016.0504.047
2. Derbyshire M. Demonstrating interchangeability and biosimilarity for US biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):139. doi:10.5639/gabij.2016.0503.035
3. Babini A, et al. New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):66-9. doi:10.5639/gabij.2016.0502.017
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
6. Flemming P. Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):94-5. doi:10.5639/gabij.2016.0502.023
7. Endrenyi L, Tóthfalusi L. Adjusted indirect comparisons between generics – bioequivalence and interchangeability. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):53-4. doi:10.5639/gabij.2016.0502.014
8. García-Arieta A. Assessment of the interchangeability between generics. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):55-9. doi:10.5639/gabij.2016.0502.015
9. Delahunty M. An empirical study of market-based purchasing policies for generic pharmaceuticals in Sweden. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):186. doi:10.5639/gabij.2016.0504.050
10. Delahunty M. Strategies used to delay or prevent access to affordable generic drugs in the US. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):188. doi:10.5639/gabij.2016.0504.051
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