Biosimilars highlights: 2019

There were many biosimilars approved in 2019, as well as new clinical trials, research into issues surrounding biosimilar use, and significant regulatory changes [1], as summarized below.

By the end of 2019, there were 58 biosimilars approved in Europe [2] and 26 biosimilars approved in the US [3], some of which are highlighted below.

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, received European approval for their adalimumab biosimilar in April 2019, while Mylan’s adalimumab biosimilar launched in Spain in July 2019 (the first of Mylan’s biosimilars to launch in the country). The US Food and Drug Administration (FDA) also approved two adalimumab biosimilars in 2019 (Hadlima, Samsung Bioepis; Abrilada, Pfizer). 2019 also saw the start of two new clinical trials for adalimumab biosimilars, from Alvotech and Celltrion.

Pfizer’s biosimilar of bevacizumab, named Zirabev, was approved for sale in the EU in February 2019. Zirabev was approved in the US and Japan in June, and in Australia in November. A bevacizumab similar biologic from Dr Reddy’s, named Versavo, was launched in India in August. There were also multiple clinical trials held for bevacizumab biosimilars in 2019, including by Amgen, Bio-Thera Solutions, and Samsung Bioepis.

The European Commission (EC) approved an infliximab biosimilar from Celltrion (named CT-P13) in September. Trial data revealed in 2019 also suggest that switching to CT-P13 is safe and well tolerated. In the US, FDA approved Amgen’s infliximab biosimilar (Avsola) in December.

In October 2019, Biocon/Mylan launched their insulin glargine biosimilar in Australia. The product is now approved in over 40 countries. In June, US generics firm Lannett started a phase I trial of their insulin biosimilar in South Africa.

There were three approvals for rituximab biosimilars in 2019, for Pfizer, Teva Canada Innovation and Shanghai Fuhong Hanlin Bio-Pharmaceutical (Hanlin).

Four new trastuzumab biosimilars were approved in 2019 in the US alone. Trastuzumab biosimilars were also approved in Canada, Australia, India and Brazil.

In terms of regulation, in March 2019 FDA issued new guidelines on the naming of biologicals, which clarified that already approved biologicals will not need to change their names.

In Canada, British Columbia stopped the coverage of certain originator biologicals and switched patients to biosimilars in 2019. The province’s healthcare system, PharmaCare, stopped providing coverage for originator biologicals for the following conditions: ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis. The latest data on biosimilar switching in British Columbia, Canada shows that 28% of patients with inflammatory bowel disease (IBD) have switched to a biosimilar version of their medication [4].

Internationally, the World Health Organization (WHO) updated their Global Benchmarking Tool, provided results for their pilot project on the prequalification of rituximab and trastuzumab, and announced a new pre-qualification scheme for insulin.

There were also a number of non-clinical research studies published in 2019, investigating important issues such as prescribing and education. A study from February assessed barriers and facilitators to biosimilar prescribing, identifying concerns about safety to be a major barrier and cost savings as an important facilitator.

A survey carried out by the European Society for Medical Oncology (ESMO) identified physician knowledge gaps on biosimilars, including understanding of biosimilar development, clinical trial design, and requirements for extrapolation. At the 17th Biosimilar Medicines Conference 2019, WHO representatives further emphasized the importance of education to increase the use of biosimilars.

Overall, 2019 has been a successful year for many in the biosimilars market. However, challenges remain, not least the fact that the number of blockbuster biologicals with patents due to expire is decreasing.

It is important to shape a sustainable and competitive biosimilars market in the future. Other recommendations for the future include increasing regulatory harmonization across countries, improving education for patients and physicians, and implementing incentives to promote biosimilar use.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China, similar biologics approved in India, or non-originator biologicals approved in Russia might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Top developments in biosimilars during 2018

Advantages and challenges of biosimilars approved in Europe and the US

Optimizing the benefits of biosimilars for society

Biosimilars highlights for 2017

References
1. Bird, E. Top developments in biosimilars during 2019. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(1):37-44. doi:10.5639/gabij.2020.0901.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apri 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apri 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. British Columbia releases latest data on biosimilar switches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/General/British-Columbia- releases-latest-data-on-biosimilar-switches

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