The Changing Landscape and Evolution of Biosimilars

If you search for “Biosimilars” in Google, you will get over 500,000 results – a massive source of information that includes scientific articles, guidelines, positions, product information, stakeholder perspectives and much more on the topic.

Biosimilars have already been the subject of  hot debate for more than a decade, and they still are.  This is very well-illustrated by looking at Google trends, which shows a steady increase of interest in this keyword between 2005 and 2015.

biosimilars

(Source: https://www.google.com/trends)

However, the specific topics around biosimilars being discussed have changed dramatically over time. Until 2006, there was no practical experience with biosimilars and most the discussions taking place were still very theoretical. Ten years later, the topic of biosimilars has evolved into something much more tangible; in Europe, we currently already have 20 biosimilars on the market (source: EMA homepage).

The views and opinions of stakeholders involved in these discussions have also changed during this period. For example, the EMA transformed its initial risk-based approach to biosimilars into a much more science-driven approach (source: DIA Biosimilar meeting 2015).  Industry associations like EBE, EBG and EuropaBio became very active in the field and published or presented their views on topics like biosimilar development, substitution of biologics and biosimilar labeling.  Furthermore, we saw healthcare professionals and patients start prescribing and using biosimilars and then become active on the topic. There have been public debates such as in workshops organised by the European Commission (DG Grow) to discuss “access to and uptake of biosimilar medicinal products.”

Initially, a large group of people could not imagine that extrapolation of data from one indication to another would be allowed; now, we are having discussions on whether or not clinical studies are still required to prove biosimilarity.  Also, where the initial focus was on how to prove similarity, discussions are now taking place on how to prove that products are interchangeable, and if additional data to demonstrate this are needed at all. An increasing number of member states are taking a clear position on this topic of interchangeability.

As you can see from the two examples above, the topic of biosimilars is very dynamic and there are still many unanswered questions. Many key stakeholders are currently still making up their minds and expressing their views on topics such as the need for clinical trials,  the level of difference one can accept between biosimilars and originators, post-authorization requirements, how far extrapolation can go, how to maximize product traceability, the risks related to immunogenicity when switching patients, and how to deal with biologics pharmacovigilance when patients are being switched from the originator to the biosimilar and vice versa.

All of these constantly evolving topics always make it interesting to follow the discussions taking place at the DIA biosimilar meeting. Stakeholders represented at the DIA Biosimilar meeting have changed, especially over the last few years, and the voice and representation of physicians, pharmacists and patients has become stronger.

Public consultations and exchanging experiences and knowledge between relevant stakeholders have proven to be a cornerstone of the well-established regulatory framework for biosimilars in Europe – a framework that has been leading the way globally. Therefore, keeping these multi-stakeholder discussions going are of upmost importance. I am pleased to see that DIA continues to provide a forum for these types of multi-stakeholder discussions.

 

Author:
Marloes van Bruggen, Regional Regulatory Policy Lead – EEMEA, F.Hoffmann-La Roche Ltd.

 

Abbreviations: 

  • EBG = European Biosimilars Group
  • EBE = European Biopharmaceutical Enterprises

 

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