- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
