Our Executive Clinical Pharmacy team takes you through the hot topics trending in biosimilars and pharmaceutical research in October 2019.
Topics included in this episode:
IPD'S DRUG & CLINICAL REVIEW:
BIOLOGICS HOT TOPICS OCTOBER 2019
“What’s happening in the world of Growth Hormone? Will some of those therapies be affected by the NDA to BLA transition?”
“Growth hormones is one of those categories where the products will soon be regulated as biologics and their NDA will transition to a BLA on March 23rd, 2020. Because of this change, it may be possible that we see additional competition via the biosimilar pathway. There are seven somatropin products that compete in the growth hormone space and aside from innovative delivery devices, there is no clinical data to differentiate them. What's actually new and exciting in the area of growth hormones is that there are three investigational drugs that are weekly products. Instead of a once daily injection, they will be subcutaneous once a week. They're currently in phase III and we expect BLA submissions sometime soon."