Publication Date:
2015-12-03
Description:
Background: Approval of a biosimilar is based on it being highly similar with regard to safety, purity, and potency and with no clinically meaningful differences when compared with a reference product.The first biosimilar, filgrastim (EP-2006), was recently approved in US.LA-EP2006 is a proposed biosimilar to the reference product pegfilgrastim (Neulasta®). Methods: This was a prospective, randomized, double-blind trial conducted in the US, Latin America, Asia and Europe. Patients with histologically proven breast cancer receiving (neo)-adjuvant TAC chemotherapy (docetaxel 75mg/m2, doxorubicin 50mg/m2, cyclophosphamide 500mg/m2) over six cycles were treated with a single 6mg SC injection of LA-EP2006 or reference pegfilgrastim on day 2 of each cycle. Primary endpoint was the duration of severe neutropenia (DSN) during Cycle 1 defined as number of consecutive days with an absolute neutrophil count (ANC)
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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