Biosimilar Clinical Trials

Extensive experience in sourcing products for biosimilar studies

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.

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 apply 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?

What is it?

Biosimilar development

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.

How do we do it?

CSI efficiently sources products for biosimilar clinical trials. We ensure the quality of products sourced globally, supplying the desired quantity with the longest possible expiry dates and within the right time frame.

Considerations for purchasing biosimilar products

Biosimilar development