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Broad and learned
clinical background

Gut Reactions #1 – a new biosimilar candidate for infliximab

Remicade (infliximab) was approved in 1998 for the treatment of Crohn’s disease and ulcerative colitis. Infliximab is a biologic drug, as opposed to a chemical drug. Biologic drugs are genetically engineered proteins derived from human genes, and are manufactured in a living system. Conversely, chemical drugs are manufactured by chemical synthesis (the combination of specific chemical ingredients in a specific way).

Pharmaceutical companies often have patents in place to ensure exclusivity of their product (whether biologic or chemical). As you may be aware, once a patent has expired for a chemical drug, generic versions are able to be manufactured and sold as an alternative to the initial branded product (this often drives down the price as a result, making the drug more freely available to patients). Generics, by definition, are the exact chemical equivalent of the chemical drug, and are manufactured in the same way, but the term ‘generic’ cannot be used in the same way to apply to biologic drugs; instead, we use the term ‘biosimilar’. This is because the development of a biologic is less straightforward, predictable and consists of many more variables. As such, it is impossible to replicate the process exactly and in its entirety. However, the important thing to remember is that both biosimilars and generics must have the same quality, safety and efficacy as the initial product.

Because of the recent expiry of the patent for the biologic drug Remicade (infliximab), Samsung Bioepis Co. Ltd. announced (March 16th 2015) that its infliximab biosimilar candidate has been submitted to the European Medicines Agency (EMA) for approval. If approved, the effect that this biosimilar would have on the lives of patients with Crohn’s disease and ulcerative colitis is significant and positive: patients would be provided with an important new treatment option, since competition between drug companies would drive down the prices, thus making this treatment option more freely available and affordable.

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