A lot has happened on the subject of biosimilars development in the past year. An important milestone for biosimilars in 2017 was the issuing of guidance on interchangeability by the US Food and Drug Administration (FDA). While the European Medicines Agency (EMA) approvals of insulin and rituximab biosimilars and the FDA’s approval of adalimumab and bevacizumab biosimilars, altogether three biosimilar cancer monoclonal antibodies have been approved in 2017, will benefit more patients worldwide to targeted biological treatments which were expensive to access in the past. Other subjects of interest for biosimilars were FDA’s update of its Purple Book for biologicals and biosimilars, as well as the studies and evolution in interchangeability, switching and substitution of biosimilars.
Biosimilars continued to be the hot topic during 2017. Biosimilarity, interchangeability and switching were the main issues covered in GaBI Online during 2017.
So what were the most viewed stories in GaBI Online during 2017? To ensure that none of GaBI Online’s readers missed out on what happened in 2017, below is a list of the top 10 most read articles in 2017. Follow the links in the titles of each article to find out more …
From this ‘most read’ articles overview, EMA and FDA approvals were the most popular, with EMA’s approval of insulin biosimilar Insulin lispro Sanofi and the rituximab biosimilars Blitzima, Ritemvia and Tuxella topping the list. This was closely followed by FDA’s approval of adalimumab biosimilar Cyltezo in third position and of bevacizumab biosimilar Mvasi in sixth position.
During 2017, EMA approved four adalimumab biosimilars (Amgevita, Cyltezo, Imraldi and Solymbic), an etanercept biosimilar (Erelzi), an insulin glargine biosimilar (Lusduna), an insulin lispro biosimilar (Insulin lispro Sanofi), two teriparatide biosimilars (Movymia and Terrosa) and six rituximab biosimilars [Rixathon, Riximyo, Truxima, Blitzima, Ritemvia and Rituzena (previously Tuxella)]. While EMA’s Committee for Medicinal Products for Human Use gave a positive opinion on bevacizumab biosimilar Mvasi and trastuzumab biosimilar (Ontruzant). These approvals bring the total number of biosimilars approved in the European Union to 38 [1].
Meanwhile, also during 2017, the US FDA approved an adalimumab biosimilar [Cyltezo (adalimumab-adbm)]. FDA also approved a follow-on insulin lispro biological (Admelog), using an abbreviated process. This brings the total number of biosimilars and follow-on biologicals approved by FDA to nine [2].
Switching and substitution of biosimilars were the next most popular topics in 2017, taking the second, eighth and 10th positions. 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 and the more recent Danish infliximab switching study, which both 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. GaBI Journal published a paper on the subject of switching during 2017 [3]. While on the subject of substitution, GaBI Journal published three full papers during 2017 [4-6].
Interchangeability is still an ongoing concern for the medical community when it comes to biosimilars. This is reflected by this topic hitting the top 10 ‘most read’ articles at the fourth and ninth positions. FDA issued draft guidance on biosimilar interchangeability on 18 January 2017. In the guidance the agency outlines its requirements for biosimilar makers looking to prove that their versions are interchangeable with the originator biologicals. However, comments on the guidance showed that there is still a lot of ambiguity surrounding the subject. Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen also discussed the difference between biosimilarity and interchangeability. He highlighted key considerations that should be addressed before any biosimilar is designated as interchangeable. On the subject of interchangeability for biosimilars, GaBI Journal published four full papers in 2017 [7-10].
GaBI organized the First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars on 20 November 2017. The meeting brought together regulators from GCC countries (Bahrain, Kuwait, Oman, Saudi Arabia) together with academics, medical practitioners/specialists, pharmacologists and pharmacists (clinical, hospital) from Saudi Arabia, to share knowledge and exchange information with experts from Italy, Norway, Saudi Arabia and the US. The aim of the meeting was to address the issues of physicochemical characterization, analytical comparability, interchangeability/substitution and safety of biologicals/biosimilars. Fifty-four participants, speakers included, attended the meeting [11].
On the subject of generics, the WHO prequalification for the first generic hepatitis C drug (1st position) was the most interesting article for GaBI Online readers. Other topics of interest included the rising costs of cancer treatments (2nd position) and the repurposing of old generic thioguanine (3rd position). On the subject of the cost of cancer treatment, GaBI Journal published two full papers on this subject during 2017 [12, 13].
In fact, the subject of price increases and what could be causing them (4th and 5th positions) was of major interest for readers in 2017, perhaps highlighting the increasing pressure on healthcare budgets. GaBI Journal published two full papers during 2017 related to this subject [14, 15].
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Related articles
Top 10 most read GaBI Online articles in 2016
Top 10 most read GaBI Online articles in 2015
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. Perks B. Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):188-9. doi:10.5639/gabij.2017.0604.042
4. Giezen T. Global policies on pharmacy-mediated substitution of biosimilars: a summary. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):155-6. doi:10.5639/gabij.2017.0604.033
5. Larkin H, Macdonald J, Lumsden R. Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):157-64. doi:10.5639/gabij.2017.0604.034
6. Reilly MS, Murby SP. A survey of Australian prescribers’ views on the naming and substitution of biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(3):107-13. doi:10.5639/gabij.2017.0603.022
7. Derbyshire M. USA and Europe differ in interchangeability of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):183-4. doi:10.5639/gabij.2017.0604.039
8. Derbyshire M. Physician associations comment on FDA’s interchangeability guidance. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(3):120-1. doi:10.5639/gabij.2017.0603.024
9. Derbyshire M. Interchangeability of biosimilars in the US and around the world. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):97-8. doi:10.5639/gabij.2017.0602.017
10. Baumgärtel C. Austrian medicines authority positive towards biosimilar interchangeability. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):41. doi:10.5639/gabij.2017.0601.009
11. GaBI Educational Forum. First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars; 20 November 2017, Riyadh, Saudi Arabia. Available from: http://gabi-journal.net/first-gcc-stakeholder-meeting-on-approval-process-interchangeabilitysubstitution-and-safety-of-biosimilars
12. Haycox A, Godman B, Wild C. Patent expiry and costs for anticancer medicines for clinical use. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(3):105-6. doi:10.5639/gabij.2017.0603.021
13. Bird E. Generic prices estimated for four novel cancer drugs. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):99-100.doi:10.5639/gabij.2017.0602.018
14. Vogler S, Schneider P. Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):79-88. doi:10.5639/gabij.2017.0602.015
15. Godman B, Hassali MA. Strategies for pricing of pharmaceuticals and generics in developing countries. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):58-60. doi:10.5639/gabij.2017.0602.013
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