Pfizer’s Retacrit ® – First biosimilar to epoetin alfa approved in the U.S.

New Drug Overview: Epoetin alfa-epbx (Retacrit®)

Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review
Epoetin alfa-epbx Retacrit ® Hospira Inc., a Pfizer company May 15, 2018 Not available n/a
Labeled Indications:
For the treatment of anemia caused by Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
For the treatment of anemia caused by Zidovudine in patients with HIV-infection
For the treatment of anemia caused by the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
For use in reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
Drug Class Comparative Drugs in Class
Erythropoiesis-stimulating agent (ESA) Epogen®/Procrit® (epoetin alfa)
Mechanism of Action:
Epoetin alfa products stimulate erythropoiesis by the same mechanism as endogenous erythropoietin.  Erythropoietin is the hormone responsible for inducing red blood cell production by the body’s bone marrow.
Clinical Trial Summary:
Clinical trials to support the approved indications were conducted in four patient groups to evaluate safety with reported adverse effects.  Tables reporting adverse effects for each are included in the package insert.

Patients with Chronic Kidney Disease

Adult Patients:

·         Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, used to identify the adverse reactions to epoetin alfa

·         Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, used to identify the adverse reactions to epoetin alfa

Pediatric Patients:

·         The pattern of adverse reactions was similar to that found in adults

Zidovudine-treated Patients with HIV-infection

·         297 zidovudine-treated patients with HIV-infection were studied in 4 placebo-controlled studies with dosing up to 12 weeks

·         Double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated patients with HIV-infection

Patients with cancer on Chemotherapy

·         16-week, double-blind, placebo-controlled study that enrolled 344 patients with anemia secondary to chemotherapy

Surgery Patients

·         Four hundred sixty-one patients undergoing major orthopedic surgery were studied in a placebo-controlled study (S1) and a comparative dosing study (2 dosing regimens, S2)

Warnings and Adverse Effects (AE):
Warning: (Black Box) increased risks of death, heart problems, stroke and tumor growth or recurrence

(Additional) include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions

AE: (Most Common) high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills
NDC

Strength

Volume Single Dose Vial (SDV) / (Multi Dose Vial (MDV)

Storage

00069-1305-01

2,000 Units/ml

1ml SDV

Refrigeration

00069-1306-01

3,000 Units/ml

1ml SDV

Refrigeration

00069-1307-01

4,000 Units/ml 1ml SDV

Refrigeration

00069-1308-01

10,000 Units/ml

1ml SDV

Refrigeration

00069-1309-01

40,000 Units/ml 1ml SDV

Refrigeration

Drug Sales Forecast (in millions):

2018(F)

2019(F) 2020(F) 2021(F) 2022(F) 2023(F)
Global $93 $127 $163 $198 $226

$252

References:

U.S. Food & Drug Administration, FDA News & Events, FDA News Release https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm  (Accessed 05/16/2018)

Product Labeling https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf  (Accessed 05/16/2018)

Pfizer, News https://www.pfizer.com/news/press-release/press-release-detail/pfizer_s_biosimilar_retacrit_epoetin_alfa_epbx_approved_by_u_s_fda (Accessed 05/16/2018)

RJ Health Systems Web Site (Accessed 05/16/2018)

Global Data, Pharma Intelligence Web Site, View Drug Overview https://pharma.globaldata.com (Accessed 05/16/2018)


For a review of the 2018 drug pipeline please click here.

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