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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.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
