How is a biosimilar different to a generic? Biosimilars are biological medicines with active substances that are highly similar, but not identical, to those of biologics that have already been authorized. To receive approval for a generic, you only need to show bioequivalence compared to the originator. Biosimilars are approved via a stringent regulatory pathway that involves demonstrating quality, safety and efficacy comparable to the original product. Biosimilars cannot be classified as ‘generics’ in the same way that chemical compounds are because of the variability of the active biotechnological substance and its complex manufacturing process.
What have been the major milestones for biosimilars? At the regulatory level, the EU was the first to develop specific guidelines for biosimilars. In addition to an overarching guideline, the EMA has also published product-specific annexes. One of the most awaited guidelines was that for biosimilar monoclonal antibodies, which came into effect in December 2012. Today, Europe is the largest biosimilars market in the world, with 19 biosimilars currently on the market. But the US is now also getting involved in biosimilars, with first biosimilar approval just recently. The biosimilars market in the US is expected by many to develop faster than that in Europe, as regulators and companies learn from experiences in Europe.
Where does your research fit it? My main interest is the development of pharmacovigilance systems for biopharmaceuticals – specifically biosimilars. Pharmacovigilance is absolutely essential in the biopharmaceuticals market because of the limited ability to predict clinical consequences of seemingly innocuous changes in the manufacturing process.
How can we minimize those risks? Manufacturing companies should design and implement a risk management plan. Risk management applies scientifically based methodologies to identify, assess, communicate and minimize risk throughout a drug’s lifecycle, so as to establish and maintain a favorable benefit–risk profile. The risk management plan for biosimilars, as well as for all originator biopharmaceuticals, should focus on heightening pharmacovigilance measures, identifying immunogenicity risk and implementing special post-marketing surveillance. Proper conduct of the pharmacovigilance program is essential. We need accurate patient records and all data must be entered into a searchable national database. The specific biopharmaceutical (originator or biosimilar) should be traceable so that effective tracking can be accomplished in the event of a clinical concern.
What are the latest developments? One of the hotter topics recently has been the issue of naming biosimilars. Stakeholders have very different viewpoints on whether biosimilars should have unique or identical names to their reference products. The World Health Organization has called for biosimilars to be assigned the same International Nonproprietary Names (INNs) as their reference biologicals, while other stakeholders, such as the Alliance for Safe Biologic Medicines (ASBM), call for the use of distinct non-propriety names for biopharmaceuticals. In my opinion, although INNs are a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialized with a brand name or the INN plus the manufacturer’s name.
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