Regulating Biosimilars: The European Model

write my papers Regulating Biosimilars: The European Model

In looking for an example of how to proceed on biosimilars, Congress should look to how the European Union created a process to move these complex bio-pharmaceutical products to market without taking unnecessary risks with patient safety.

The European system recognizes that biosimilars are fundamentally different from the original reference biologic pharmaceuticals. Created from distinct living cells under a different manufacturing process, European regulators and legislators determined that even slight differences between the innovator product and biosimilars can significantly alter a biologic drug’s safety and effectiveness.

Legislation subsequently passed by the European Parliament prioritized patient safety by establishing a regulatory framework that requires extensive testing before any new approval of a biosimilar. Subsequently, The European Medicines Agency (EMEA), Europe’s equivalent to the Food & Drug Administration (FDA), has implemented a process that specifically distinguishes between biosimilars and generic drugs. The EMEA recognized that there may be safety and efficacy differences between seemingly similar products and reviews each new biologic on a case-by-case basis.

The EMEA determined that clinical trials are necessary because similar biological products may have a different safety profile from the reference product even if the efficacy is comparable. Notably, the EMEA recognized the need for post-marketing monitoring due to the potential for a biosimilar to exhibit immunogenicity problems that were not detected in clinical trials and do not occur with the original reference product.
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