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EU takes the lead in shaping the future of biosimilars

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The sixth European Generic Medicines Association Symposium on Biosimilar Medicines took place in London on 24–25 April, with the theme of developing market pathways that benefit patients

Romayne Stephens

HPE Reporter

The past five years have seen a tremendous amount of activity in the field of biosimilar medicines, with the European Medicines Agency (EMEA) implementing legislation and developing a broad portfolio of guidelines. And with the first of these products now on the market, the EU can take its place as the world leader in biosimilar medicines in both regulatory and legal terms.

But one important question remains: how quickly can patients benefit from the EU’s lead in this field?

Rapid access to these therapies relies on the development
of market pathways that benefit patients. This was the common thread linking presentations at the European Generic Medicines Association (EGA) symposium.

In his keynote address, John Purves (head of sector, pre-authorisation evaluation of medicines for human use, EMEA) explained: “One of the benefits we have at the EMEA is exceedingly good contact with colleagues in the European Commission. Because of that contact and dialogue we can actually look not at the legislation in isolation, not at the science in isolation, but we can look at them together and see how they meet so that we can have the best possible regulation for medicinal products in Europe.”

He said opportunities had already arisen to develop an efficient regulatory system, with the implementation of an integrated quality management system throughout the EU network, the implementation of new legislation in line with the EMEA’s roadmap, the management of the EU regulatory network to fully and adequately implement all the latest tools available
as part of the new legislation, and the evolution of procedures and processes.

He reiterated that the EMEA’s mission was to foster scientific excellence in the evaluation and supervision of medicines, adding: “Behind all of that is the fact that we want to make medicines accessible to patients within Europe.

“Over the last 20 years there have been changes to the science, the legislation and the way in which dossiers are reviewed. We have much more sophisticated review procedures that allow us to make decisions, not only in relation to quality, safety and efficacy, but also in relation to risk management plans.

“The EC, EMEA and industry – we are all interested in providing information and products for use by the healthcare providers within the community, and all of this really is to supply good-quality and safe medicines to the patients.”

Steps would now be taken to further strengthen the European medicines network to boost efficiency in:

  • Improving medicine safety.
  • Contributing to earlier availability of medicines.
  • Fostering transparency, communication and provision of information.
  • Increasing the EMEA contribution to the regulationof medicines globally.

“After six years, we have a much clearer picture now regarding biosimilar medicines, but there are still some other things we need to deal with.” More debate is needed, he said, on the issues of international nonproprietary names and interchangeability. “That has to be done among the interested parties,” he added.

Emphasising the importance of trusted information to patients and transparent communication, he said: “If you look back, it is important to see the benefits that have arisen from the fact that all interested parties have been involved in the development of the legislation and in the development of the guidelines for biosimilar products. And I would not underestimate the importance of the working parties that the EMEA has held to actually share that information with all
interested parties.”

Looking ahead, he pinpointed three main challenges to the further development of regulatory guidance on biosimilars:

  • Communication – in particular, the need to be transparent and science-driven, and to clearly outline national and EU responsibilities.
  • Technical/regulatory harmonisation, by adopting a consistent national approach – for example, in relation to policies on use of biosimilars.
  • Pharmacovigilance, to boost product identification and traceability in case of adverse events.

The decision-making process
Arnold Vulto (hospital pharmacist/pharmacologist, Erasmus University Medical Centre, Rotterdam, Netherlands) addressed the issue of guidance for decision-making for biopharmaceuticals.

He said hospital pharmacists were primarily looking for reliable supplies, products that were easy to use and decreasing levels of uncertainty.

Professor Vulto noted that EU patents for several drugs had expired, or would be doing so within the next few years. These included growth hormones, interferons, insulin, epoetin, interleukin, G-CSF, human fertility hormone and TNF antagonists. Biopharmaceutical versions of several of these already existed, with EU licences granted for growth hormone in
2006 (Omnitrope/Valtropin, reference product Genotropin/
Humatrope), erythropoetin in 2007 (epoetin alfa: Abseamed, Binocrit, Epoetin alfa Hexal; epoetin zeta: Silapo, Retacrit; reference product Eprex, epoetin alfa) and filgrastim (G-CSF) in 2008 (Ratiograstim, Biograstim, Tevagrastim, Filgrastim; reference product Neupogen).

He then posed the question: “How do we prepare the structured decision to include biosimilars in hospital pharmacies? You have to collect the information about the product. Every biopharmaceutical, innovative or biosimilar, carries some uncertainties, and we need to reduce these uncertainties.”

Professor Vulto asserted that biosimilars were a logical next step in a developing drug market. And, while acknowledging that every new biopharmaceutical on the market carried some risk, he said biosimilars had “intrinsically reduced uncertainties” as they “build on the experience of the originator product”.

He pointed out that biosimilars fulfilled basic quality requirements just as every other new drug did, and as such they were suitable for use in patient care. But he emphasised the importance of “track and trace” to deal with unforeseen situations, advising that uncontrolled substitution should be avoided and that any substitution should take place only after consultation with the treating physician.

Professor Vulto expressed the hope that eventually biosimilars would add to market dynamics and eventually lower prices and treatment costs, “so we have more money available for innovative therapies”.

Biosimilar thinking
Christian Schneider (acting divisional head, Paul Ehrlich
Institute, Langen, Germany; chairman, Biosimilar Medicinal Products Working Party, CHMP) gave an overview of the activities of the working party he leads. He emphasised the fact that thinking on biosimilar had evolved, adding: “We have to ask ourselves, how far does the characterisation go? There are new developments in biotech.”

Recognising the importance of briefing meetings with industry, Dr Schneider acknowledged that the BMWP needed to keep track of what was going on in the field to facilitate the development of novel methodologies, both for better characterisation of biosimilarity and for tackling consequences – for example, immunogenicity.

The BMWP, he said, has to learn from industry where issues with these new products require frameworks to be adapted, or where new concepts are required. “Immunogenicity is always coming up when we talk about biosimilars, but obviously this is not only an issue for biosimilars.” On monoclonal antibodies, he
said: “We need to start the discussions among regulators. What would be a biosimilar antibody? How far does similarity go?”

The Canadian perspective
Anthony Ridgway (senior regulatory scientist, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada) offered an insight into Health Canada’s perspective on “subsequent-entry biologics” (SEBs, ie, biosimilars or follow-on protein products), demonstrating comparability and other regulatory issues.

He said Health Canada – Canada’s federal department for health – was developing a formal regulatory process for SEBs. Important elements in establishing comparability, and various challenges to the industry and to regulators, would be discussed.

He acknowledged that some attitudes towards biosimilars had changed. “Over the years I have seen rather polarised positions towards this type of product on either side, which have now become a bit more softened. Recognising some intermediate position makes a lot of sense. I think that the formalisation of
the approaches that has taken place in the European Union has done a lot to contribute to that,” he said.

Canadian regulators have been referring to these products as “SEBs” for about nine years, but are now starting to adopt the term biosimilars in line with the EU.

Referring to International Conference on Harmonisation (ICH) Q5E guidance, he added: “The principles captured in Q5E are still relevant to biosimilars. There are challenges. But how can one ignore the fact that a highly similar product may have been used in perhaps millions of patients over the previous 10–15 years? Our argument is that one should not, and somehow
one has to figure that knowledge about an active ingredient into the decision-making process.”

It is too early to predict what effect biosimilar medicines will have on the healthcare landscape, but there is no denying that the biosimilars market is on the threshold of rapid expansion. In the long run this can only be a good thing, as wider use of biosimilars will help to make healthcare more affordable and result in increased patient access to lifesaving therapies.



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