Replies to post #107712 on Biotech Values

[zipjet]

I would not hesitate to use it myself.

Why would you take the higher HIT risk?


Differential Interaction of Anti-heparin Platelet Factor 4 Antibodies with Branded and Generic Versions of Low Molecular Weight Heparins. Pathophysiologic and Bioequivalence Implications.
Jawed Fareed, Debra Hoppensteadt, Omer Iqbal, Cafer Adiguzel, Harry Messmoreand Jenaine Walenga
Pathology, Loyola University Medical Center, Maywood, IL
ABSTRACT
Low molecular weight heparins (LMWHs) such as enoxaparin (E) and dalteparin (D) are now widely used for the management of thrombotic and cardiovascular complications. Several generic versions of these drugs have recently become available. Due to the compositional differences in the branded agents, such as E and D, their interactions with platelet factor 4 (PF4) differ and potentially have impact on immunogenic responses.Similarly, because of the apparent differences in the source material and oligosaccharide composition, obvious differences in PF4 titration have been noted. To compare the potential interactions of D and one of it’s generic versions daltehep (DH) and E and two of its generic versions, namely, lupenox (LU) and loparan (LO), each of these agents were tested in an in vitro heparin induced platelet aggregation (HIPA) system, where pooled serum from clinically diagnosed heparin induced thrombocytopenia (HIT) patients was used as an antibody source. Significant differences in the aggregation responses were noted between D and E. Therewas no difference in D and DH (30.8 ± 7.8% vs. 34.7 ± 8.1%). However, significant differences between E (18.2 ± 4.2%), LO (38.1 ± 9.0%) and LU (68.1 ± 9.1%) were noted. These results underscore the observation that HIT antibodies interact differentially between the branded and generic LMWHs, owing to their oligosaccharide composition.