The growth in the biosimilar market since 2006 has been significant. The ambition of biosimilar development is to prove high similarity in terms of biological activity, efficacy, safety, and immunogenicity.
Biosimilars in Clinical Trials
Clinical trials are carried out to prove that the biosimilar can rely on the efficacy and safety experience of the reference biological treatment.
Clinical trials for biosimilars do not need to include all of the studies necessary for the reference medicine to prove patient safety and efficacy.
Services
Based on comprehensive comparability studies with reference medicine, our packages provide further evidence of our strengths and provoke robust and rigorous data on each biosimilar clinical trial. These data packages ensure no eloquent clinical differences in:
○ Efficacy
○ Safety
○ Immunogenicity
This data is needed to demonstrate biosimilarity for high-quality biosimilars' regulatory approval.
Insights &
Resources
Request For Proposal
We offer unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries.
