According to the results of a survey carried out with Chinese and European industry experts, from the point of view of company executives, clinical, regulatory and commercial experts, the challenges that nowadays Chinese companies have to face are, by order of importance:
1. Clinical development
2. Find the right licensing partner
3. Meeting regulatory requirements for EMA (European Medicines Agency) approval
4. Find the right distributor(s)
5. Presence of strong competitors in Europe
6. Price competition and erosion in Europe
7. Complexity of reimbursement and market access
8. Manufacturing and supply for European markets
9. Stigma regarding Chinese company and products

From the European companies’ view on Chinese biosimilars companies:
1. European companies see Chinese companies as emerging competitors
2. With a lower cost already assumed, they pose a threat in price competition
3. They are depending on the capabilities of their EU partner companies
4. Some have the potential to become a truly global player
5. There is not a real concern (under the radar)

Based on a few case studies, the important consideration of cross-border market expansion for biosimilars are:
A. From the Chinese companies’ point of view
1. Clinical development
– Plan for global trials that meet EMA requirements
– Apply for EMA Scientific Advice
– Prepare for complete dossier (CMC, pre-clinical and clinical data)

2. Commercial competitiveness
– Develop assets with potential to be early to market
– Minimize cost structure to support competitive advantages on cost and price
– Employ internal and/or external expertise on business development and due diligence to select the right partner

B. Going to China
– Be aware of the intense local competition and price pressure
– Bring the ‘right’ assets early

C. Competing in Europe
– Focus on early to market
– Continuously drive for supply chain and manufacturing efficiency

Experience from Europe and the US has revealed that the success of the biosimilar market is closely linked to the creation of a strong commercial ecosystem that informs physicians and patients of this new therapeutic class and ensures the availability of drugs through an efficient supply chain [2].

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
Challenges for Chinese companies to bring biosimilars (copy biological) to EU

Pathways for Chinese pharmaceutical companies to enter EU markets

Chinese biosimilars (copy biological) in European markets

China approves Factor VIII copy biological Anjian

Access to biosimilars in China, the EU and the US

References
1. International Commercialization of Biosmilars. Focus on Chinese biosimilars entering European markets. PowerPoint presentation Jenny Hao. 9 November 2021, Basel, Switzerland.
2. GaBI Online - Generics and Biosimilars Initiative. Challenges facing copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 16]. Available from: www.gabionline.net/reports/Challenges-facing-copy-biologicals-in-China

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