Celltrion said Friday that it will begin clinical phase 1 trials of its Prolia biosimilar CT-P41 in September.
The study aims to test CT-P41’s safety in healthy participants and is anticipated to wrap up in the first half of 2021.
Celltrion said it plans to finish clinical phase 3 trials by February 2025 when Prolia’s patent in the US will expire. CT-P41, as a biosimilar, gets to bypass clinical phase 2 trials given that it proves its similarity to the original drug.
Prolia as an osteoporosis treatment currently rakes in an annual revenue of 3.2 trillion won ($2.7 billion) according to Amgen’s 2019 financial report.
Celltrion said that it hopes CT-P41 will become a complementary pipeline to its existing biosimilars -- Remsima, Truxima and Herzuma.
Celltrion Healthcare, the logistics arm of Celltrion, has posted upbeat second-quarter earnings, marking an 868 percent on-year increase in its operating profit at 86.8 billion won. Its net profit increased 448 percent on-year to 46.4 billion won.
The company credited this record growth on the biobetter Remsima SC’s increased sales amid the COVID-19 pandemic.
By Lim Jeong-yeo (firstname.lastname@example.org)