In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The European Medicines Agency (EMA) first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then the agency has developed many general and specific guidelines for biosimilars [1]. Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 [2]. To date, EMA has recommended the approval of 64 biosimilars for marketing in Europe, six were subsequently withdrawn, leaving 58 approved biosimilars [3]. Marketing of approved biosimilars usually occurs immediately following approval in Europe.

In the US, on the other hand, the country’s drug regulator, the US Food and Drug Administration (FDA), only approved its first biosimilar, Zarxio (filgrastim-sndz), in March 2015 [4]. To date, the agency has approved 26 biosimilars, plus 3 follow-on biologicals, and has also granted tentative approval to a teriparatide follow-on biological (PF708), pending patent litigation [5]. However, only nine of these approved biosimilars are on the market [6].

China started approving copy biologicals before any guidance was in place, but finally introduced guidance on the subject in February 2015 [7]. Prior to the guidance, the country approved four copy biologicals (with one being later withdrawn). Since the guidance has been in place the country has approved four copy biologicals (Anjianning [adalimumab], Ankeda [bevacizumab], Hanlikon [rituximab] and Qletli [adalimumab]), the first of which was Hanlikon (rituximab) in February 2019 [8].

Both the US and China were significantly behind the EU in starting to approve biosimilars/copy biologicals. However, despite the small number of copy biologicals approved in the country, China has been much faster to commercialize such products. In fact, Yisaipu (etanercept) was even approved earlier than the originator drug.

Finally, accessibility to these treatments has certainly been improved in China, with the lowering of the cost for patients. For example, the prices of Anjianning and Ankeda were reported as 11%−16% lower than the negotiated National Reimbursement Drug List (NRDL) prices for the originator drugs in 2019.

The first trastuzumab copy biological is also expected to be approved in China in 2020 and is expected to be commercialized soon afterwards.

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 might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Readers interested to learn more about barriers to market uptake of biosimilars in the US are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Barriers to market uptake of biosimilars in the US

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Related article
Obstacles to the use of biosimilars in the US

References
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6. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market%20
7. Derbyshire M. Regulation of copy biologicals in China. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):75-6. doi:10.5639/gabij.2018.0702.015
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