Scientific, legal and regulatory challenges facing biosimilars development

Biosimilars/Research | Posted 11/12/2020 post-comment0 Post your comment

Abbreviated approval pathways for biosimilars – biological products that are highly similar to an originator biological with regard to quality, safety and efficacy [1, 2] – were created to foster competition and lower prices for biological treatments. However, these desired effects have not materialized as quickly as expected in either the US or the European Union.


Challenges that could influence biosimilar development include the expensive and complex manufacturing process required to produce biosimilars [3]. Biosimilars developers must reverse-engineer the originator product, which can be protected by trade secrets and patents, as well as meet more rigorous standards for approval than those required for the approval of small-molecule generics [4, 5].

Druedahl et al. [6] investigated key scientific, legal and regulatory challenges in biosimilars development and their effect on biosimilar market entry. Through qualitative interviews, they identified the perceptions that European national medicines regulators and pharmaceutical manufacturer employees or consultants with experience in biologicals had regarding the challenges for biosimilars development.

The study participants described trade secrets as a surmountable barrier to biosimilar development, but patents protecting the originator biological as a key obstacle. This – the study participants explained – was due to numerous patents protecting each originator biological, which must be navigated around and are difficult to identify. The study participants further identified a lack of alignment between regulators’ desire for flexibility and companies’ need for certainty concerning how to meet approval standards.

Druedahl et al. conclude that measures to increase the transparency of biological patent landscapes, as well as the clarity and uniformity of regulatory requirements, could help facilitate biosimilars development to the benefit of patients and healthcare systems [6].

Conflict of interest
The authors of the research paper [6] reported conflict of interest, including being an employee of the Copenhagen Centre for Regulatory Science (CORS). CORS is a cross-faculty university-anchored institution involving various public (Danish Medicines Agency Copenhagen University) and private (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) stakeholders, as well as patient organizations (Rare Diseases Denmark). For full details of the authors’ conflict of interest, see the research paper [6].

Abstracted by Louise C Druedahl, MScPharm, PhD candidate. Copenhagen Centre for Regulatory Science (CORS)/Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark.

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1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. Barriers to the market access of biosimilar monoclonal antibodies []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: 
4. Price WN 2nd, Rai AK. Drug Development. Are trade secrets delaying biosimilars? Science. 2015;348(6231):188-9.
5. Price WN 2nd, Rai AK. How logically impossible patents block biosimilars. Nat Biotechnol. 2019;37(8):862-3.
6. Druedahl LC, Almarsdóttir AB, Kälvemark Sporrong S, et al. A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nat Biotechnol. 2020;38(11):1253-6.

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