It has once again been a busy year for biosimilars. One of the most important milestones for biosimilars in 2019 was the World Health Organization (WHO) pilot programme to prequalify rituximab and trastuzumab biosimilars. Other subjects of interest for biosimilars were US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, naming and regulation of biosimilars, as well as biosimilar guidance, uptake and switching.
Biosimilars remained the most widely covered topic in GaBI Online during 2019. Below is a list of the top 10 most read articles in 2019. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, the issue of naming for biosimilars was the most popular, topping the charts. This covered a literature review, which found that the differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake. The literature review by Michael Sarshad and colleagues was published in GaBI Journal [1].
FDA approvals were also very popular, with FDA’s approval of adalimumab biosimilar Hadlima coming in second position on the list. This was followed by FDA’s approval of rituximab biosimilar Ruxience in third position.
The acceptance by EMA of the first ‘China-developed’ biosimilar, in the form of proposed trastuzumab biosimilar (HLX02) came in at number four in the Top 10 most read.
During 2019, EMA approved two adalimumab biosimilars (Idacio and Kromeya), a subcutaneous form of infliximab (Remsima SC) and a pegfilgrastim biosimilar (Pegfilgrastim Mundipharma). An adalimumab biosimilar (Cyltezo) and a rituximab biosimilar (Rituzena, previously Tuxella) were also withdrawn. This brings the total number of biosimilars approved in the European Union to 56 [2].
The fifth most popular article was the WHO pilot programme to prequalify rituximab and trastuzumab biosimilars. WHO announced the pilot for prequalifying biosimilars in October 2017 [3]. It was confirmed that the pilot for the prequalification of these drugs was launched in June 2018. Rituximab and trastuzumab are among the first monoclonal antibody therapies to be listed in WHO Model List of Essential Medicines. In fact, in December 2019, WHO successfully prequalified its first biosimilar; trastuzumab supplied by Samsung Bioepis. The biosimilar was found to be comparable to the originator product in terms of efficacy, safety and quality, and is now eligible for procurement by United Nations agencies and for national tenders [4]. In November 2019, WHO also launched a prequalification programme for biosimilar insulin [5].
With increasing demand for harmonization between regulators in different regions across the globe, it is perhaps not surprising that an article on achieving consistent regulation for biosimilars also made it into the top 10 ‘most read’ articles, in sixth position. Dr Gillian Woolett of healthcare consultancy Avalere Health, gave a presentation focusing around the biosimilars market in the US at the 17th Biosimilar Medicines Conference in The Netherlands. The latter half of her presentation focused on regulatory issues, particularly the need for consistent application of regulatory principles for biological drugs. She said there needs to be more awareness that all biological drugs vary – whether they are reference product or biosimilar – in order for biosimilars to succeed in the US.
At the same conference, WHO outlined a new Q&A document to assist with the regulatory evaluation of biosimilar products. The article covering the content of this presentation hit the top 10 ‘most read’ articles at number seven. WHO says that its Q&A document complements the existing guidelines and deals with a number of issues regarding licensing biosimilars, reference biologicals, quality, non-clinical and clinical evaluation and pharmacovigilance.
Uptake of biosimilars in Europe, and indeed across the world, is still lower than expected in many countries, despite the fact that biologicals have had a profound impact on health care and the fact that biosimilars have the potential to increase access to these often life-changing products. This was discussed in the article that came in at number eight in the list. Dr Jaclyn Bosco and Mr Murray Aitken of IQVIA state reasons for the slower than expected uptake in Europe may include the lack of automatic substitution of biosimilars for originator products and the fact that many doctors and patients are reluctant to switch or substitute, given their lack of familiarity with biosimilars.
In fact, ongoing concerns from the medical community about switching biosimilars are reflected by an article on switching hitting the top 10 ‘most read’ articles in ninth position. In this article, authors Marc Scherlinger and Thierry Schaeverbeke commented on the paper from Glintborg and co-authors ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [6]. Scherlinger and Schaeverbeke point out that there are two strategies for switching patients from more expensive originator biologicals to biosimilars, with their 20%‒50% lower costs, either a shared decision or a mandatory switch. They also point out that switching to a biosimilar via a physician–patient shared decision has been favoured by rheumatology scientific societies, by an international consensus group and by patient associations.
Finally, in 10th position, the US Food and Drug Administration’s (FDA) final guidance on the pathway for interchangeable biologicals was of interest for many readers. The guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product’.
On the subject of generics, China’s auditing of drug companies (first position) was the most interesting article for GaBI Online readers. Other topics of interest included FDA guidance for developers of complex generics (second position) and recommended solutions for drug shortages in the US (third position).
Excessive prices for generics in the US (fourth position) and EMA approval of two generics for fungal infections (fifth position), were also subjects of interest for readers in 2019.
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Related articles
Top 10 most read GaBI Online articles in 2018
Top 10 most read GaBI Online articles in 2017
References
1. Sarshad M, Campbell R, Pitts PJ, et al. The need for distinct nomenclature for originator and biosimilar products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(4):152-7. doi:10.5639/gabij.2018.0704.031
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-consultation-on-prequalification-of-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. WHO launches insulin prequalification programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-insulin-prequalification-programme
6. GaBI Online - Generics and Biosimilars Initiative. Danish etanercept switching study investigates withdrawal rates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/Research/Danish-etanercept-switching-study-investigates-withdrawal-rates
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