Profil is an expert on biosimilar insulins
In the past Profil has worked on biosimilar insulins a lot. We are the leading provider of bioequivalence trials for these insulins and with our next generation glucose clamp technology, ClampArt, we offer several advantages for carrying out such trials. Especially for fast acting insulins the advantages of using automated glucose clamping become apparent and easy to understand. With the much better time-resolution, important time points can get resolved better and results are more reliable.
See the many resources below to learn more about biosimilar insulins and Profil capabilities:
- On-demand online seminar on biosimilar insulins
- Blog post on biosimilar insulins
- Our website dedicated to the topic
- Download a recent conference poster on biosimilars
You see, Profil is the expert when it comes to the topic of insulin biosimilars.
Peer reviewed biosimilar insulin study published
We are proud to be adding to the array of resources available on this topic. In February we published a peer reviewed paper in the journal "Diabetes, Obesity and Metabolism". You can get the paper here. In this study we compared the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 rapid-acting insulin lispro products. These were SAR342434 solution, United States (US)-approved Humalog and European Union (EU)-approved Humalog.
Check out this paper to see how to design such a bioequivalence trial.
If this topic is interesting to you, then register for our blog and don't miss future news. We are going to publish soon an analysis of the new American guidelines for biosimilars. This will certainly stir up the regulatory landscape and maybe the developmental plans for many biosimilar companies.
Also, you may be interested in our online seminar on biosimilar insulin development. Watch this interesting and free session to learn how to comply with the EU guidelines on biosimilar insulin development.