A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosimilars market, biosimilar policies in Europe, position statements on biosimilars and interchangeability and switching.
Biosimilars remained as the widely covered topic in GaBI Online during 2018 and below is a list of the top 10 most read articles in 2018. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, the EMA approval of the adalimumab biosimilar Hulio and the pegfilgrastim biosimilars Pelgraz and Udenyca was the most popular, topping the charts.
During 2018, EMA approved four adalimumab biosimilars (Halimatoz, Hefiya, Hulio and Hyrimoz), two bevacizumab biosimilars (Mvasi and Zirabev), an infliximab biosimilar (Zessly), an insulin glargine biosimilar (Semglee), four trastuzumab biosimilars (Herzuma, Kanjinti, Ogivri and Trazimera) and four pegfilgrastim biosimilars (Pelgraz, Pelmeg, Udenyca and Ziextenzo). These approvals bring the total number of biosimilars approved in the European Union to 59 [1].
The second most popular article was the study examining the performance of Zarxio (filgrastim-sndz) during its first year in the US short-acting filgrastim market. This article concluded that ‘it would not be necessary for first-to-market biosimilar entrants to employ aggressive discounting tactics to gain market share’. However, during 2018, two biosimilars, Udenyca (pegfilgrastim-cbqv) and Retacrit (epoetin alfa-epbx), were launched at a significant discount (33% and 57%, respectively) to the brand-name biological in the hope of capturing a significant market share [2].
Interchangeability and switching were also popular topics in 2018, taking the 4th and 9th positions. While the American Society of Clinical Oncology (ASCO) position statement, which also discussed interchangeability and switching, came in at the third position. The ASCO article also discusses the issues surrounding naming, labelling, safety and efficacy, and substitution of biosimilars, as well as the value of biosimilars and prescriber and patient education. In 2018, GaBI also organized its 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars [3].
FDA rejected four biosimilar applications during 2018 (fifth and sixth positions). It rejected Celltrion’s candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars in April 2018. However, the company resubmitted its applications to FDA in May 2018 [4, 5] and received approval for Truxima (rituximab-abbs) and Herzuma (trastuzumab-pkrb) in November and December 2018, respectively [6, 7]. The agency also rejected Pfizer’s candidate trastuzumab biosimilar in April 2018 and Sandoz’s candidate rituximab biosimilar in May 2018. Sandoz then announced in November 2018 that it had decided not to pursue rituximab in the US [8].
The article on FDA’s update on the agency’s naming policies for biologicals/biosimilars was the seventh most-read article. FDA’s finalized guidance assigns a non-proprietary name for all originator biologicals, related biologicals and biosimilars that includes a ‘FDA-designated suffix’ that is devoid of meaning. However, this guidance has been accused of being an obstacle to the use of biosimilars in the US [9]. In addition, the Generic Pharmaceutical Association (GPhA), has said that the guidance has the potential ‘to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety’ [10]. On the subject of naming, GaBI Journal has published a full paper by Michael Reilly and Peter J Pitts [11].
In light of ongoing austerity measures in many countries, it is perhaps not surprising that an article on the cost of biosimilars made it into the top 10 (eighth position). The European Biopharmaceutical Enterprises (EBE) survey on pricing and reimbursement policies for off-patent biologicals in Europe found that there have been shifts in biologicals policies and their implementation since the last EBE survey, particularly regarding substitution and interchangeability.
Finally, in the 10th position, biosimilar policies in Europe was a topic that interested many readers. This article discussed how differences in biosimilar policies, e.g. pricing and reimbursement procedures, levels of education, characteristics of covered population and incentivization of stakeholders, have led to variations in uptake of biosimilars and divergences in savings from biosimilars use across European countries.
On the subject of generics, FDA’s list of companies that block generics (first position) was the most interesting article for GaBI Online readers. Other topics of interest included the creation of a non-profit generics company by four of the US’s largest hospital systems (second position) and adverse outcomes for elderly patients using generic versus brand-name angiotensin II receptor blockers (ARBs) (third position).
Switchback rates between generic and brand-name drugs (fourth position) and the FDA being sued by Teva Pharmaceutical Industries for changing its ‘first applicant’ definition for generics (fifth position), were also subjects of interest for readers in 2018.
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Top 10 most read GaBI Online articles in 2017
Top 10 most read GaBI Online articles in 2016
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars launched in the US at a significant discount [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-launched-in-the-US-at-a-significant-discount
3. 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars 2018. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018. Available from: www.gabi-journal.net/about-gabi/educational-workshops/2nd-mena-stakeholder-meeting-on-regulatory-approval-clinical-settings-interchangeability-and-pharmacovigilance-of-biosimilars-2018
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar trastuzumab to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-resubmits-biosimilar-trastuzumab-to-FDA
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar rituximab to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-resubmits-biosimilar-rituximab-to-FDA
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
7. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from:
8. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim and Sandoz abandon biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/General/Boehringer-Ingelheim-and-Sandoz-abandon-biosimilars
9. GaBI Online - Generics and Biosimilars Initiative. Naming is an obstacle to the use of biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/Research/Naming-is-an-obstacle-to-the-use-of-biosimilars-in-the-US
10. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting
11. Reilly MS, Pitts PJ. Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(3):97-100. doi:10.5639/gabij.2018.0703.021
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