More Filters. Current and future biosimilars: potential practical applications in rheumatology. Highly Influenced. View 10 excerpts, cites background. Challenges for biosimilars: focus on rheumatoid arthritis. Biosimilars: Review of regulatory, manufacturing, analytical aspects and beyond.
Abstract Biologics have more complex production processes compared to small-molecule drugs. They may even prove labile when drifting from batch-to-batch or in different production locations. The … Expand. Biosimilars in IBD: hope or expectation? View 2 excerpts, cites background.
Biosimilars: what clinicians should know. Biosimilars: Concepts and controversies. Biosimilars: Are They Bioequivalent? Abstract: Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication.
The confusion is not just a potential concern for patient safety and efficacy, but also can lead to misconceptions in published reports. Several examples of this have occurred, some of which are discussed below. The definitions provided should be adopted for clarity in the future. Biosimilars are now firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval, which allows marketing of safe and efficacious biological products.
The comparability studies required for comparing the innovator reference product and the potential biosimilar product are crucial for the regulatory process and guarantee the quality and clinical performance of the biosimilar. Clear guidelines have been produced by the Committee for Medicinal Products for Human Use and its working parties, describing the desired criteria including quality, non-clinical and clinical studies needed for biosimilars and requirements for their regulatory approval in the EU [ 1 — 5 , 20 ].
The comparability of quality aspects required is significant and some data from such studies have been partially published [ 6 , 7 ]. To date, 14 marketing authorisations have been approved for biosimilars in the EU and many more are in the pipeline. Outside the EU, several countries have adopted an identical or similar regulatory approach to the EU for approval of biosimilars, e.
Australia, Canada, Japan. Unfortunately, inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products. This problem of terminology and its implications has been the subject of a recent publication by Weise et al. Several examples of this have already occurred, some of which are discussed below. A case of pure red cell aplasia PRCA in an end-stage renal disease patient associated with induction of antibodies to administered erythropoietin EPO was described in India [ 10 ].
However, there is no evidence that this product has been approved using the comparability approach required in the EU for biosimilarity and described in the WHO and other guidelines.
This is in fact unlikely as the Indian regulatory process at that time did not include biosimilars or follow-on products and approved non-innovator products based on a stand-alone system [ 11 ].
Thus the product Wepox which is not a biosimilar and should not be described as such as this clearly misleads the reader by using incorrect terminology.
In some cases, the type of product referred to in studies is unclear. The procedure adopted for approval of the locally produced EPOs is not reported, but is unlikely to be via the biosimilar route as the Korean biosimilar guideline was produced only recently. The Korean regulatory process however includes both comparative biosimilar and non-comparative procedures, and use of correct terminology in publications would avoid ambiguity and misunderstanding.
These products were produced in Argentina, China, India and South Korea, and 14 different such products were approved for use in Thailand.
However, none of these products were really biosimilars as all were approved using the process employed for chemical generics, i.
This report is particularly misleading as the implication is that biosimilar EPOs are more likely to cause antibody induction and PRCA than innovator products which is not shown in the study as none of the products used were biosimilars in the sense of correct terminology. It is particularly important that correct terminology for biosimilars is used in reviews highlighting their potential importance.
However, this is often not done. Again, this is a clear misuse of terminology. There has been considerable discussion of the pros and cons of biosimilar G-CSFs in the literature. However, in many cases, it is not clear whether products referred to as biosimilars are really biosimilars. For example, in a review of the use of G-CSF for mobilization of stem cells [ 15 ], an Argentinean product Neutromax is described as a biosimilar although it has not been approved using the biosimilar procedure [ 16 ].
A glaring example of misleading terminology is evident in a recent publication [ 17 ], from Iran describing a comparative study in multiple sclerosis patients receiving Avonex an innovator beta interferon IFN product and Cinnovex a locally produced non-innovator beta IFN product. Published : 01 August Issue Date : August Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article.
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