Nesbell (darbepoetin alfa biosimilar) / Fuji Pharma, Chong Kun Dang, Alvogen, Biocon - LARVOL DELTA

The Benefits of Darbepoetin Alfa (Nesbell®) for Chronic Kidney Disease Patients (KSN 2023) - "Sponsored by ChongKunDang Pharm."

Clinical • Chronic Kidney Disease • Nephrology • Renal Disease

Chong Kun Dang to export anemia biosimilar ’Nesbell’ to Middle East [Google translation] (Korea IT Times) - "Chong Kun Dang announced...that it had signed an export contract with Menage Pharmaceutical Industries, an Oman's pharmaceutical company, for Nesbell, the second-generation anemia treatment biosimilar. Under the deal, Chong Kun Dang will supply finished Nesbell products to Menagene and receive down payment and milestone for each development stage. Menagene plans to sell Nesbell exclusively to six countries in the Middle East including Oman, Saudi Arabia, the United Arab Emirates, Kuwait, Qatar and Bahrain."

Commercial • Anemia

Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP) Biosimilar, to Those of NESP After a Single Subcutaneous or Intravenous Administration to Healthy Subjects. (PubMed, Drug Des Devel Ther) - "Both CKD-11101 and reference drug were generally well tolerated. After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug."

Clinical • Journal • PK/PD data

Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP) Biosimilar, to Those of NESP After a Single Subcutaneous or Intravenous Administration to Healthy Subjects (Dovepress) - P1, N=31; NCT01684605; P1, N=34; NCT01685671; "No statistically significant differences were noted in the maximum baseline adjusted reticulocyte count or the area under the baseline adjusted reticulocyte count-time between the CKD-11101 and reference drug after IV or SC dose (all p-value> 0.05). Both CKD-11101 and reference drug were generally well tolerated."

PK/PD data

Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study. (PubMed, BioDrugs) - "The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis."

Clinical • Journal • P3 data

Lotus licenses Aranesp biosimilar from Chong Kun Dang (The Pharma Letter) - "The deal granted Lotus the exclusive right to commercialize CKD's biosimilar of Amgen’s Aranesp (darbepoetin alfa) - the second generation epoetin to treat chronic renal failure - in Taiwan and Southeast Asian countries."

Licensing / partnership • Anemia

Domestic No.1 'Neps biosimilar', soon to be released next month (Medi-consumer News) - "...the approval of CKD-11101 is finally under review at the Food and Drug Administration. It is expected to be approved as early as next month and as late as December. The company expects CKD-11101 to be approved in the second half of this year."

FDA event

Chong Kun Dang receives approval for sales of anemia biosimilar (Business Korea) - "Chong Kun Dang Pharmaceutical...announced...that it has recently received sales approval for its second-generation anemia biosimilar 'CKD-11101' from the Ministry of Food and Drug Safety of South Korea....CKD is planning to start selling CKD-11101 in the domestic market within 2019."

Biosimilar launch • Non-US regulatory • Anemia

Two darbepoetin alfa biosimilars submitted to Japan’s MHLW (GaBI) - "...South Korean drugs firm Chong Kun Dang Pharmaceutical (CKDP) announced that it had submitted an application for approval of its proposed darbepoetin alfa biosimilar, CKD‑11101, to Japan’s MHLW."

Japanese regulatory • Anemia

Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. (PubMed, Curr Med Res Opin) - P3 | "CKD-11101 has an equivalent therapeutic effect as NESP in chronic kidney disease patients with renal anaemia. CKD-11101 can be safely used for long-term treatment and in patients converted from NESP."

Clinical • Journal

Efficacy and Safety of CKD-11101 (Darbepoetin-Alfa Proposed Biosimilar) Compared with Darbepoetin Alfa in Patient on Hemodialysis (KIDNEY WEEK 2019) - "CKD-11101 has an equivalent therapeutic efficacy compared with the darbepoetin-alfa in patient undergoing hemodialysis. Funding Commercial Support"

Clinical

Chong Kun Dang’s first biosimilar wins green light for marketing in Japan (Pulse News) - "South Korea’s Chong Kun Dang (CKD) said on Tuesday that it received a regulatory nod in Japan to manufacture and sell the world`s first NESP biosimilar (CKD-11101) to treat anemia in the country....CKD will also export finished CKD-11101 products to Mylan’s Japanese entity. Sales are due in December after drug price registration."

Japanese regulatory

Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with Darbepoetin alfa in patient on hemodialysis (KSN 2019) - "The difference in change of the level of Hb, dose of EPO, and achievement rate to target Hb during study period was comparable between two groups. CKD-11101 has an equivalent therapeutic efficacy compared with the darbepoetin-alfa in patient undergoing hemodialysis."

Clinical