Europe’s IP framework should support earlier authorization of biosimilars, review finds

Biosimilares/Investigación | Posted 04/03/2022 post-comment0 Post your comment

A review of the European Pharmaceutical Strategy suggests the framework should focus on intellectual property (IP) initiatives that support the earlier authorization of biosimilars.

Intellectual Property V13E17

In the drug market, IP protects originator products and influences the development of more affordable copies, including generics and biosimilars. In a study published in GaBI Journal [1], researchers conducted a review of IP for biological drugs in Europe.

The review aimed to describe and discuss the IP framework in the EU and its impact on access to biological medicines. It used data from the European Medicines Agency (EMA) on authorizations and patent and exclusivity expiry dates of biological medicines.

The analysis found that (as of July 2021) 1,238 medicines were authorized for use in Europe, include 332 biologicals. Of these however, only 55 were authorized biosimilars (covering 17 unique biologicals).

The researchers say there are increasing authorizations for biological drugs in Europe but significant delays in applications for marketing authorization for biosimilars. These delays can be attributed to the complexity of development, IP protection of the originator, and trade secrets for manufacturing processes.

The analysis confirmed that the pharmaceutical industry benefits from the IP framework which gives originator biologicals monopoly status, resulting excessive pricing. To rectify this, the authors say that the European Pharmaceutical Strategy should focus on IP programmes that support the earlier authorization of biosimilars, as well as new biologicals.

They make specific recommendations towards achieving this goal including:
  • Knowledge sharing
     o Knowledge sharing can improve access to medicines, as demonstrated by the COVID-19 vaccines. Similar knowledge sharing should be considered for biologicals where accessibility is critical.
  • Simplification of the regulatory framework
     o Regulations governing European IP should be revised to reduce complexity and bureaucracy, which can lead to abuse of the incentive system.
  • Changing IP protection rights
     o IP protection rights are a major contributing factor to monopoly and therefore pricing of biologicals, which are disproportionate to the cost of development.
  • Transparency in pricing and R & D costs
     o Another way to address excessive pricing of biologicals is through greater transparency.
     o The European Commission has already called for transparency in costs of R & D, including costs obtained from public funding.
     o WHO has published a report on improving transparency providing policy recommendations to Member States when negotiating prices for medicinal products, including implementing legislation on pricing transparency, using caution when entering in confidentiality agreements with manufacturers, and implementing price regulation.
     o In practice, progress on uptake of measures related to transparency is slow and requires more commitment from Member States.
     o Procurement at EU level provides higher bargaining power when negotiating with the pharmaceutical industry and is important for achieving timely, equitable and affordable access to biologicals.

Overall, the authors conclude that the EU Pharmaceutical Strategy should revise its IP system to ensure timely, equitable and affordable access of biological medicines to all citizens.

Conflict of interest statement
The authors of the study [1] declare no competing interests.

Editor’s comment
Readers interested to learn more about the biosimilars market in Europe are invited to visit to view the following manuscripts published in GaBI Journal:

Policy recommendations for a sustainable biosimilars market: lessons from Europe

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

A white paper: US biosimilars market on pace with Europe

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 7 February 2022)

Submit a manuscript to GaBI Journal

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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1. Sciberras J, Zammit R, Vella Bonanno P, et al. The European framework for intellectual property rights for biological medicines. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(4):172-83. doi:10.5639/gabij.2021.1004.022

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