Home / Reports / Improved regulation favouring copy biologicals in China

Improved regulation favouring copy biologicals in China Posted 09/04/2021

Europe’s drug regulator, the European Medicines Agency (EMA) was the first agency around the world to establish regulatory guidelines for biosimilars back in 2005 [1]. This more favourable regulatory environment has enabled Europe to lead the way in the adoption of biosimilars. In fact, Northern Europe has world leading biosimilar adoption rates, helped by its local tendering systems and national policies encouraging physician-led switching [2].

The US introduced a regulatory approval pathway for biosimilars in 2009 via its Biologics Price Competition and Innovation Act (BPCI Act). The first biosimilar, Zarxio (filgrastim-sndz), however, was only approved in the US in 2015 [3], or 24 years after the originator biological first hit the market. There has also been a very slow uptake of biosimilars in the country [4, 5] and, as a result, only 2% of biosimilar sales come from the US, compared to 87% in Europe, despite the fact that 59% of global biological sales come from the US.

In China, the need to reduce healthcare expenditure for its rapidly ageing population is a major driver fuelling the use of generics and copy biologicals. The country is therefore looking for ways to reduce healthcare costs and is taking a proactive approach to solving this problem, including developing alternatives to expensive brand-name drugs (including the recent GPO/4+7 tender trial).

China’s drug regulator, the National Medical Products Administration (NMPA), published draft copy biologicals guidance in 2014 [6]. A finalized technical guidance for the development and evaluation of copy biologicals was released in 2015 [7]. The guideline defines a copy biological as a ‘therapeutic biological product that is similar to the approved reference biological in terms of quality, safety and efficacy’ and requests the amino acid sequence of the biosimilar to be the same as that of the reference biological.

Building upon the 2015 guidelines, China’s Center for Drug Evaluation (CDE), which is part of the NMPA, also published draft guidance on clinical trials for adalimumab, bevacizumab, denosumumab and trastuzumab copy biologicals [8-11].

The Chinese government has also released two lists of ‘Priority Drugs’ (48 drugs in the first list and 30 in the second list) with urgent clinical needs with the aim of encouraging pharmaceutical companies to bring more products to the Chinese market. The lists focus on new drugs for the treatment of rare diseases that have already been or are actively being marketed in the US, the European Union or Japan, but have not been made available in China, as well as new drugs for the prevention and treatment of life-altering or life-threatening diseases for which no effective treatments have been made available, or those drugs with obvious clinical advantages. If there is no ethnic difference in the clinical study, sponsors of these drugs can submit the clinical trial data obtained overseas and directly apply for the drug listing registration. The CDE will accelerate the approval process by establishing priority review and approval procedures. Notably, the list includes a number of biologicals, among them Humira (adalimumab) and Levemir (insulin detemir).

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.

Related articles
Investment increasing pipeline of copy biologicals in China

Patent expiries may drive development of copy biologicals in China

Cancer driving the need for copy biologicals in China

The state of play for copy biologicals in China

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References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars 
2. GaBI Online - Generics and Biosimilars Initiative. Switching statins in Norway after new reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Generics/Research/Switching-statins-in-Norway-after-new-reimbursement-policy 
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. Lack of confidence in biosimilars slowing uptake in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Reports/Lack-of-confidence-in-biosimilars-slowing-uptake-in-the-US 
5. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market
6. GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines 
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
8. GaBI Online - Generics and Biosimilars Initiative. China publishes draft guideline for adalimumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-publishes-draft-guideline-for-adalimumab-copy-biologicals 
9. GaBI Online - Generics and Biosimilars Initiative. China publishes draft guideline for bevacizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-publishes-draft-guideline-for-bevacizumab-copy-biologicals 
10. GaBI Online - Generics and Biosimilars Initiative. China publishes draft guideline for denosumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-publishes-draft-guideline-for-denosumab-copy-biologicals 
11. GaBI Online - Generics and Biosimilars Initiative. China publishes draft guideline for trastuzumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-publishes-draft-guideline-for-trastuzumab-copy-biologicals

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Source: Hogan Lovells

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