Launch of "Darbepoetin Alfa BS Injection [JCR]" for the Treatment of Renal Anemia

Kissei Pharmaceutical Co., Ltd. (head office: Matsumoto, Nagano, Chairman and CEO: Mutsuo Kanzawa; "Kissei") announced today that "Darbepoetin Alfa BS Injection [JCR]" will be launched on November 27, 2019 in Japan for the treatment of renal anemia.

Kissei and JCR Pharmaceuticals Co., Ltd. (head office: Ashiya, Hyogo, Chairman and President: Shin Ashida; "JCR") co-developed Darbepoetin Alfa BS Injection [JCR] which is a biosimilar of darbepoetin alfa (generic name), a long-acting erythropoiesis-stimulating agent. Darbepoetin Alfa BS Injection [JCR] will be manufactured by JCR, while its medical information provision and marketing activities will be handled by Kissei. Kissei will leverage our experience cultivated from marketing and commercializing.

In the clinical studies of Darbepoetin Alfa BS Injection [JCR], it demonstrated equivalence in quality and efficacy compared with darbepoetin alpha (innovator product) along with similarity in safety profile. JCR subsequently received manufacturing and marketing approval in September 2019, and this drug will be listed on the NHI drug price list on November 27, 2019.

Kissei will leverage our experience cultivated from Epoetin Alpha BS Injection [JCR], on sale since May 2010. We aim to further contribute to the field of renal disease treatment and offer a new option for patients with renal anemia by providing Darbepoetin Alfa BS Injection [JCR].


<Product Summary>
Brand Name:
Darbepoetin Alfa BS Injection 5μg Syringe [JCR]
Darbepoetin Alfa BS Injection 10μg Syringe [JCR]
Darbepoetin Alfa BS Injection 15μg Syringe [JCR]
Darbepoetin Alfa BS Injection 20μg Syringe [JCR]
Darbepoetin Alfa BS Injection 30μg Syringe [JCR]
Darbepoetin Alfa BS Injection 40μg Syringe [JCR]
Darbepoetin Alfa BS Injection 60μg Syringe [JCR]
Darbepoetin Alfa BS Injection 120μg Syringe [JCR]
Darbepoetin Alfa BS Injection 180μg Syringe [JCR]

Generic Name:
Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1]

Indications:
Renal anemia

Dosage and Administration:
<Patients undergoing hemodialysis>
-Initial dosage

In adults: Usually, 20 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is intravenously administered once every week to adults.
In children: Usually, 0.33 μg/kg (not to exceed 20 µg) of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is intravenously administered once every week to children.

-Initial dosage when switched from erythropoietin preparations (Epoetin Alfa [Genetical Recombination], Epoetin Beta [Genetical Recombination])

In adults: Usually, 15 to 60 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is intravenously administered once every week to adults.

-Maintenance dosage

In adults: After the anemia improvement effect is observed, usually 15 to 60 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is intravenously administered once every week to adults. If the anemia improvement is maintained by administration once every week, change to administration once every two weeks with twice the dose at that time as a starting dose, and once every two weeks 30 to 120 μg can be intravenously administered.
In children: After the anemia improvement effect is observed, usually 5 to 60 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is intravenously administered once every week to children. If the anemia improvement is maintained by administration once a week, change to administration once every two weeks with twice the dose at that time as a starting dose, and once every two weeks 10 to 120 μg can be intravenously administered.
In any case, the dosage may be changed depending on anemic symptoms or the patient's age, but shall not exceed 180 μg at a time.

<Patients undergoing peritoneal dialysis and with chronic kidney disease at a prior stage of dialysis treatment>
-Initial dosage

In adults: Usually, 30 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to adults.
In children: Usually, 0.5 μg/kg (not to exceed 30 µg) of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to children.

-Initial dosage when switched from erythropoietin preparations (Epoetin Alfa [Genetical Recombination], Epoetin Beta [Genetical Recombination])

In adults: Usually, 30 to 120 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to adults.
In children: Usually, 10 to 60 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to children.

-Maintenance dosage

In adults: After the anemia improvement effect is observed, usually, 30 to 120 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to adults. If the anemia improvement is maintained by administration once every two weeks, change to administration once every four weeks with twice the dose at that time as a starting dose, andonce every four weeks 60 to 180 μg can be subcutaneously or intravenously administered.
In children: After the anemia improvement effect is observed, usually, 5 to 120 μg of Darbepoetin Alfa (Genetical Recombination) [Darbepoetin Alfa Biosimilar 1] is subcutaneously or intravenously administered once every two weeks to children. If the anemia improvement is maintained by administration once every two weeks, change to administration once every four weeks with twice the dose at that time as a starting dose, and once every four weeks 10 to 180 μg can be subcutaneously or intravenously administered.
In any case, the dosage may be changed depending on anemic symptoms or the patient's age, but shall not exceed 180 μg at a time.

Date of Drug Price Listing:
November 27, 2019

Date of Launch in Japan:
November 27, 2019

Distributed by:
Kissei Pharmaceutical Co., Ltd.

Manufactured and Distributed by:
JCR Pharmaceuticals Co., Ltd.