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| | | | | Biosimilars | | | | | | | What are biosimilars?
Biosimilars are reproductions of biotechnologically manufactured biopharmaceuticals that partially mimic proteins naturally present in the body.
Biopharmaceuticals are produced by cultivating genetically modified organisms in closed reactors with special nutritive media. In the subsequent purification process, all contaminants are removed from these proteinogenic active substances, paving the way for their use as highly purified active components in formulations and further processing to produce pharmaceutical preparations.
Primary sources of host organisms include animal cell cultures that are highly suited to producing proteins naturally present in the body. When it comes to certain deficiency diseases, these proteins are not produced by the body, or are not produced in sufficient qualities, and need to be administered to patients as part of a substitution therapy. For example, hemophilia is caused by a factor VIII deficiency and is treated with doses of genetically manufactured factor VIII.
In contrast to traditional chemical substances consisting of low molecular molecules with a uniform chemical structure, many biotechnologically manufactured active agents, and the naturally occurring active substances that they reproduce, are characterized by a microheterogeneity that results in a complex mixture of very similar yet non-identical molecules. Even when identical manufacturing processes are used, the occurrence of microheterogenetic characteristics (often caused by posttranslational modifications) can cause compositions to vary slightly. These fluctuations are limited by strict specifications and validated in clinical tests.
In light of these fluctuations, biosimilars are not identical to original preparations or naturally occurring substances in the body. This is why the biosimilars industry uses terms such as "follow-on biologics" and "similar biological medicinal products". Whereas new chemical generic drugs are often granted a fast-track approval that waives the conducting of clinical tests, biosimilars have to submit to extensive studies. In Europe, authorization for biosimilars is granted, not by national regulatory authorities, but by the central European Medicines Agency, the EMEA in London. The EMEA has begun to specify the regulations for biosimilars in position papers that reflect the views of the agency with regard to the approval process.
For the reasons cited above, the development and manufacture of biosimilars differs significantly from the development and manufacture of traditional chemical generics. The research and development necessary to produce biosimilars can also require funding in the two-digit million-euro range. In addition to these financial demands, biosimilars require comprehensive experience in the development and manufacture of proteinogenic pharmaceuticals. This provides a basis for exploring new and innovative areas of business that can help reduce the costs of the health care system.
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