Biosimilar Clinical Trials
What are Biosimilars?
A biosimilar medicine is a biological medicine that is developed to be highly similar and clinically equivalent to an existing biological medicine. A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as the ‘reference medicine’ or ‘originator medicine’. It is similar to the reference medicine in terms of quality, structural characteristics, biological activity.
The aim of biosimilar development is to demonstrate biosimilarity – high similarity in terms of structure, biological activity, efficacy, safety, and immunogenicity – based on comprehensive comparability studies with the reference medicine. By demonstrating biosimilarity, a biosimilar can rely on experience gained with the reference medicine, thereby avoiding repetition of clinical trials (i.e. if a biosimilar is highly similar to a reference medicine in one therapeutic indication, safety and efficacy data may be extrapolated to other indications for which the reference medicine is already approved).
The first biosimilars, both somatropins, received their marketing authorisation from the European Commission in 2006. The list continues to grow, and the latest information can be found on the EMA website, https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
Considerations for purchasing Biosimilar products
Biosimilar medicines are approved to be therapeutic equivalents to the reference medicine, establishing that the previously proven safety and efficacy of that medicine also applies to the biosimilar. As with any biological medicine, the biosimilar medicine will have details of its licensed indications included in the British National Formulary.
Those making decisions about whether to purchase a biosimilar should consider the following questions:
Is the biosimilar licensed for all the indications and routes of administration required?
Is the biosimilar available in suitable strengths and presentations?
Is the administration device acceptable to the patient and are product associated support services available?
We have extensive experience in sourcing products for biosimilar studies where even the site of production might have an impact on the product license. For example, there can be very strict Government regulations in place in some countries. However, we can offer reliable supplies.
We are able to:
- • Purchase directly from innovator companies if required
- • Secure large quantities and supply global studies where disclosure is not desirable
- • Ensure pedigree of products as well as continuity of supply
- • Provide different batches and longest possible expiry dates
- • Source specifically for analytical purposes, products of a certain batch and subsequently supplying significant quantities once our client has undertaken analytical testing.
The below are all products that we have provided for Biosimilar Studies: