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:
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:
What is it?
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.