Biosimilars are the most widely-used and well accepted term for similar biological medicinal products but there are several more which are used in English: biogenerics, subsequent entry biologics, biocomparables, similar biotherapeutic products, follow-on biologics, similar biopharmaceuticals, me-too biologics, non-innovator proteins…
As well known, European Medicines Agency, EMA is the leading regulatory authority for biosimilars and the members of Biosimilar Medicinal Products Working Party (BMWP) has recently published an article in Nature Biotechnology to address the problems arising from the usage of the term biosimilar.
In Europe, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is responsible for the scientific assessment of human medicines that follow the European ‘centralized procedure of marketing authorization’. According to this legislation, all recombinant proteins must undergo this route for licensing. As most biosimilars are recombinant proteins, they usually have to follow this centralized route.
According to the EU guidelines, a biosimilar is a copy version of an already approved originator (reference product) with demonstrated similarity in physicochemical characteristics, efficacy and safety, based on a comprehensive comparability exercise.
Biosimilar manufacturers, do not have access to the originators’ prorietary data and therefore they need to develop their own processes in order to manufacture a “similar” biological product. This means that, although a reduction in the data requirements is possible for biosimilars in the EU, the data package required is nevertheless substantial.
Different terms emerged in different parts of the world for copy versions of original biological medicinal products as mentioned above. In addition, different definitions of the same term in different geographical locations add to the semantic confusion.
Authors identifed some problematic issues as:
– Some noninnovator epoetins showed significant differences in physicochemical characteristics and potency
– Also some noninnovator epoetins exhibited very high batch-to-batch variability
– Some low molecular weight heparins already marketed outside the EU and the United States should also not be labeled biosimilars because it is not clear whether they were developed in a comparative manner
– Furthermore, different formulations of botulinum toxin A do not qualify as true biosimilars because of obvious differences in physicochemical characteristics, doses and dosing regimens
– Second-generation proteins should not be described as biosimilars because of the differences in the primary structure
– And lastly, a physican expressed his doubts about biosimilars as “they may not even contain active substance” which is completely meaning the “counterfeit medicines“. Biosimilars can not be evaluated in the same table with counterfeits.
For these reasons, the authors suggest that ‘any copy version of a therapeutic protein, which has not been developed and assessed in line with the scientific principles of a strictly comparative development program against a reference product, should not be termed biosimilar’. Using a consistent and clear terminology will prevent confusion between biosimilars and other copy versions of original biological medicinal products, and ensure their safe use.
The authors also noted that, the previously used term “follow-on protein products (follow-on biologics)” was recently changed to biosimilars in the US.
And lastly, their proposals for a more precise terminology is as follows:
What is your opinion? Do you agree with the authors or think that “one-size fits all” approach can be enough and all noninnovator products can be named as biosimilars? If you wanna contribute please use the form below…
Reference: Weise M, Bielsky M, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars—why terminology matters. Nature Biotechnology. 2011;29:690–3