Eye on Pharma: Chong Kun Dang's Darbepoetin Alfa Biosimilar Approved
This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.
This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.
Like epoetin alfa, darbepoetin alfa treats anemia in patients who have chronic renal insufficiency or who are undergoing chemotherapy for solid cancer. Both drugs work by stimulating the bone marrow to produce more red blood cells. However, darbepoetin alfa was developed with an altered structure that extends its elimination half-life and allows for a longer dosing interval than epoetin alfa.
Other Asian drug makers are hoping for approvals of their own for darbepoetin alfa biosimilars. Dong-A ST is seeking regulatory approval of its darbepoetin alfa product in Japan; the company has filed an application for its DA-3880 with Japanese regulators in October 2018 in the hope of gaining a share of a Japanese market for darbepoetin alfa that is worth the equivalent of $439 million. Additionally, Kissei Pharmaceutical Company and JCR Pharmaceuticals announced positive results of a phase 3 study for JR-131 earlier this year.
Meanwhile, the originator product is being repositioned in the Asian marketplace; in August 2018, Japanese drug maker Kyowa Hakko Kirin announced that its subsidiary, Kyowa Kirin Frontier, had been awarded a manufacturing and marketing approval for an “authorized version” of the reference darbepoetin alfa in an injection syringe presentation.
While Chong Kun Dang’s product is the first biosimilar of the brand-name Aranesp to be granted approval in a highly regulated territory, some drug manufacturers have already launched biosimilars of darbepoetin alfa in less highly regulated territories; companies such as Hetero Drugs, Dr. Reddy’s Laboratories, and Torrent Pharmaceuticals have all launched darbepoetin alfa biosimilars in India, some as early as in 2010.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
