EMA risk management plans may increase prescriber confidence in biosimilars

Biosimilars/Research | Posted 10/02/2012 post-comment0 Post your comment

In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescriber confidence in the compounds [1].

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The objective of a risk management plan is to protect patients from harmful events by ensuring that the benefits of a medicine exceed its risks by the greatest achievable margin. Typically, a plan consists of two parts: in part I, the safety profile of the medication is described and pharmacovigilance activities are proposed, e.g. collecting spontaneously reported adverse events, the development of post-authorisation safety studies. Part II evaluates the necessity for risk minimisation activities and provides an action plan for each potential safety concern. The proposed risk management plans for all new biosimilars are freely available on the EMA website.

Although biosimilars are ‘copies’ of existing biopharmaceuticals, the recombinant processes used in their manufacturing often differ from that of the originator compound. This means that despite the achievement of an identical pharmacological effect, biosimilars have the potential to cause adverse events that may not match the originator compound.

This hypothesis was proved in 1998 when a reformulated version of the innovative erythropoietin alpha product (Eprex) was launched worldwide. With such widespread use, it soon emerged that the incidence of drug-related pure red cell aplasia had increased. Although the debate surrounding the aetiology of this immunological reaction is yet to be resolved, an unfortunate lesson was learned: manipulating a biopharmaceutical formulation may put patients at risk.

Since the introduction of the EMA’s risk management plans in 2005, safety-related biosimilar issues have been minimal. These successes have provided a safe foundation for confident biosimilar prescribing, with some experts believing that biosimilars can now be viewed as equally as efficacious and safe as their reference (originator) compound.

If you would like to receive a copy of Professor Vulto’s article discussing this subject, please email us.

Editor’s comment
The French medicines review journal, La Revue Prescrire, has demanded that EMA makes ‘all’ observational safety information public—not just a compound’s proposed risk management plan. This includes Periodic Safety Update Reports which would contain confidential information about additional safety measures implemented during the phase IV observational period, e.g. the initiation of additional clinical studies, planned long-term follow-up of treated patients, etc. We believe that not publishing these data is counter-productive to a biosimilar’s success.

Even at the time of launch, any new clinical entity is a ‘work in progress’, with observational data continuing to be collated throughout the compound’s lifespan. In the first couple of years post-launch, clinical experience with a biosimilar is at its lowest, and given that biosimilar manufacturers are not currently obliged to publish observational data, prescribers may have to rely on their own limited anecdotal biosimilar experiences. The originator compound, on the other hand, may have extensive published phase IV data, so clinicians relying on a solid evidence base may choose to continue to prescribe the tried-and-tested innovator compound.

With this in mind, readers are reminded that all pre- and post-launch biosimilar data can be considered for publication by GaBI Journal. If you are interested in contributing a research article in a similar area to GaBI Journal, please email us your submission.

Related article

Clinical biosimilar data should be accessible to all


1.  Vulto AG, Crow SA. Risk management of biosimilars in oncology: each medicine is a work in progress. Oncologie. 2011;13(5):196-200.

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