Biosimilar studies are clinical trials that aim to prove that a newly created version of a medication is the same as an existing one that’s already been approved for use for the public. The new version is created due to expiry of the drug patent.

For people looking to participate in clinical trials, it can mean that any outcomes or side effects from the drug are often better predicted as they are expected to be similar.

These kinds of studies are important as they can provide more affordable options for patients, improving their accessibility to important medicines. If you’ve ever considered joining a study read on.

Why do we have or need Biosimilar studies?

All investigational drugs and medicinal treatments are required to go through robust clinical trials before they are approved for use in New Zealand and around the world. Once they are approved, these ‘treatments’ are usually patented for a period of time, providing the company that developed the investigational drug with protection from another company producing the same drug. Pharmaceutical patents work much like Registered Trademarks or Copyright for art or music. They allow the company holding the patent with the exclusive rights to manufacture the ‘innovative’ product for a period of time – in order to recoup their extensive development and launch costs.

However, when a patent expires on a pharmaceutical product, other manufacturers can then create similar drugs to treat the same condition or symptom. Just think about all the different brands of paracetamol that exist now that Panadol is ‘off-patent’. Patients benefit from the lower cost of medicines and consulting physicians have wider options to prescribe, comforted in the knowledge that the replica treatment works in a similar way, with similar outcomes, as the original investigational medicine.

What is a Biosimilar Study?

The safety and efficacy of Biosimilars are tested through comparative studies. This means that while on the study, participants have a 1 in 3 chance of receiving either the new drug, the approved drug, or the placebo (which has no active ingredient). The treatment option that’s given to participants is random to ensure that there are no biases.

Many of these off-patent drugs are known as “generic drugs”, Paracetamol being a great example of a generic drug. However, if the drug is made from a living organism (as is the case in some vaccines and treatments for conditions such as cancer) they are called “biosimilars.” The key differences between a ‘generic’ and a ‘biosimilar’ are its molecular structure and a usually far higher cost and complexity involved in the development of a biosimilar.

Like the drug it was based on, the biosimilar is a similar drug, manufactured by a different company. Drug approval organisations throughout the world, rightly demand that the biosimilars go through the same medical testing and approval protocol as the innovative medicine, to prove efficacy, effectiveness and document any side effects.

Biosimilar studies, therefore, are usually more predictable in their outcomes and side effects than original investigational drug clinical trials. The treatment being trialed is expected to react in much the same way as the original innovator treatment reacted. For this reason, many medical trial participants feel very comfortable participating in a biosimilar study.

Regardless, at NZCR (New Zealand Clinical Research), we treat every clinical trial, be it for biosimilars or for investigational treatments, with the utmost caution, providing 24/7 medical supervision and regular health checkups.

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