Biotech Values

[mouton29]

Other Lovenox "generics":

I think this one (Cutenox) may be substitutable in Sri Lanka. Perhaps of some relevance to the recent interest in immunogenicity, this abstract (from the FASEB journal) presents some data comparing
Cutenox to Lovenox.

951.6
Differential Immunogenic Responses of Branded and Generic Versions of Low Molecular Weight Heparins
Eduardo Ramaciotti1, Marisa Gomez1, Jeanine M. Walenga2, Debra Hoppensteadt2, Gundu Rao3, Helena Nader4, Walter Jeske2 and Jawed Fareed2

1 Univ. of Michigan, Ann Arbor, MI
2 Loyola University Medical Center, Maywood, IL
3 Lillehei Heart Institute, Minneapolis, MN
4 Universidade Federal de Sao Paulo, Sao Paulo, Brazil

ABSTRACT

Low molecular weight heparins (LMWHs) are complex mixtures of oligosaccharides. Compositional and structural features impact their biological effects including their interaction with endogenous proteins such as platelet factor 4 (PF4). Purified PF4 was titrated with the branded LMWHs dalteparin (Fragmin), enoxaparin (Lovenox), and reviparin (Clivarin) and two generic versions of enoxaparin (Cutenox and Lupenox). The prevalence of anti-heparin/PF4 antibodies (HIT antibodies) in patients treated with approved regimens of branded products and Cutenox were investigated in plasma samples obtained 7–10 days after the administration of these drugs. Marked differences in the PF4 titration among branded products were noted in the aPTT, Heptest, TT, and amidolytic anti-Xa, anti-IIa assays. HIT antibody prevalence and the antibody sub-typing profile was significantly different among the branded products (18–32 %). While there were pharmacodynamic differences between Lovenox and Cutenox, there was no significant difference in the global (IgG, IgA, IgM) titers of HIT antibodies. Sub-typing of the antibodies demonstrated a greater prevalence of IgG type antibodies (those implicated in mediating the pathologic responses in HIT) in the plasma from patients treated with the generic LMWH. These studies suggest that the compositional differences in LMWHs may result in differential immunogenic responses.

http://www.fasebj.org/cgi/content/meeting_abstract/24/1_MeetingAbstracts/951.6?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Pharmacodynamic+differences+between+biosimilar&searchid=1&FIRSTINDEX=0&volume=24&issue=1_MeetingAbstracts&resourcetype=HWCIT