Delving into the Latest Updates on Epoetin alfa biosimilar(Biocon Biopharmaceuticals Pvt Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Epoetin alfa biosimilar, Erypro, Erypro Prefil

+ [2]

Target

EPO receptor

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Anemia

Inactive Indication-

Originator Organization

Biocon Biopharmaceuticals Pvt Ltd.

Active Organization

Biocon Biopharmaceuticals Pvt Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Jan 2011),

Anemia

Regulation-

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Gene Sequence

Sequence Code 9003

The sequence is quoted from: *****

European and US guidelines for renal anaemia management recommend subcutaneous (s.c.) epoetin as the preferred route of administration in pre-dialysis, peritoneal dialysis and haemodialysis patients. However, the restriction of Eprex/Erypro to intravenous (i.v.) administration in Europe has increased the interest of health care professionals regarding the optimal route of administration for all epoetin formulations. There are five major considerations for the 'optimal' route of epoetin administration: efficacy; dosing frequency; convenience; safety and tolerability; and cost. Although epoetin bioavailability is lower after s.c. administration, its efficacy is higher, owing to its prolonged elimination half-life compared with i.v. epoetin. Several studies and clinical surveys comparing s.c. and i.v. administration have demonstrated that equivalent target haemoglobin levels can be maintained at much lower doses of epoetin when administered s.c. Furthermore, s.c. epoetin dosing frequency can be reduced in some patients to once every 2 weeks, without compromising efficacy. Devices such as the Reco-Pen have been specifically designed to facilitate self-administration of s.c. epoetin-beta. An upsurge in the incidence of pure red cell aplasia (PRCA) was linked to the epoetin-alpha product Eprex/Erypo in Europe, and an increase in PRCA cases of the same magnitude was not seen in patients taking other epoetin products s.c. Therefore, PRCA should not be used as an argument against s.c. administration. The reduced dose with s.c. administration of epoetin-beta provides significant cost benefits, without compromising either safety or efficacy, and may also increase patient satisfaction and compliance with treatment.

100 Deals associated with Epoetin alfa biosimilar(Biocon Biopharmaceuticals Pvt Ltd.)

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