Premium
Recommendations on biosimilar low‐molecular‐weight heparins
Author(s) -
HARENBERG J.,
KAKKAR A.,
BERGQVIST D.,
BARROWCLIFFE T.,
CASU B.,
FAREED J.,
MISMETTI P.,
OFOSU F. A.,
RAAKE W.,
SAMAMA M.,
SCHULMAN S.
Publication year - 2009
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/j.1538-7836.2009.03349.x
Subject(s) - biosimilar , chemistry , pharmacology , medicine
Summary. Based on the results of large clinical trials, several low‐molecular‐weight heparins (LMWHs) have been approved for prophylaxis and the treatment of venous and arterial thromboembolism. As a result of expiration or pending expiration of patent protection of the originator LMWHs, many generic or biosimilar LMWHs have been approved in some countries and more are likely to be approved elsewhere. Their greater availability may reduce the treatment costs. The Working Party on Requirements for Development of Biosimilar LMWHs of the Subcommittee on Control of Anticoagulation, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis has reached a consensus on recommendations to ensure the quality of biosimilar LMWHs as compared with the originator LMWHs.