A working group of clinicians and scientists was formed to review the clinical considerations for use of low-molecular-weight heparin (LMWH) biosimilars. LMWH are biological molecules of significant complexity; the full complexity of chemical structure is still to be elucidated. LMWH biosimilars are products that are biologically similar to their reference product and rely on clinical data from a reference product to establish safety and efficacy. The complex nature of LMWH molecules means that it is uncertain whether a LMWH biosimilar is chemically identical to its reference product; this introduces the possibility of differences in activity and immunogenicity. The challenge for regulators and clinicians is to evaluate the level of evidenc...
Walter Jeske,1 Jeanine M Walenga,1 Debra Hoppensteadt,2 Jawed Fareed2 1Cardiovascular Institute; 2De...
Abstract Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of ...
Abstract Biologicals are distinct from small molecule drugs in that they are larger, more structural...
Low molecular weight heparins (LMWHs) represent a class of compounds widely used in the prophylaxis ...
The term "biosimilars" is used to qualify products developed to be similar to an original biological...
International audienceBased on the results of large clinical trials, several low-molecular-weight he...
See also Gray E, Mulloy B. Biosimilar low molecular weight heparin products. This issue, pp 1218–21....
The protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the e...
Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different br...
Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfra...
The recent health care changes and approval of a generic low-molecular-weight heparin (LMWH) by the ...
Biosimilars are biological medicinal products marketed as a copy of an originator (reference) produc...
In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acr...
AbstractVarious branded low molecular weight heparins (LMWHs) have been used for the treatment and p...
Biomedical products are complex molecules, produced by living cells, molecules that are naturally pr...
Walter Jeske,1 Jeanine M Walenga,1 Debra Hoppensteadt,2 Jawed Fareed2 1Cardiovascular Institute; 2De...
Abstract Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of ...
Abstract Biologicals are distinct from small molecule drugs in that they are larger, more structural...
Low molecular weight heparins (LMWHs) represent a class of compounds widely used in the prophylaxis ...
The term "biosimilars" is used to qualify products developed to be similar to an original biological...
International audienceBased on the results of large clinical trials, several low-molecular-weight he...
See also Gray E, Mulloy B. Biosimilar low molecular weight heparin products. This issue, pp 1218–21....
The protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the e...
Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different br...
Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfra...
The recent health care changes and approval of a generic low-molecular-weight heparin (LMWH) by the ...
Biosimilars are biological medicinal products marketed as a copy of an originator (reference) produc...
In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acr...
AbstractVarious branded low molecular weight heparins (LMWHs) have been used for the treatment and p...
Biomedical products are complex molecules, produced by living cells, molecules that are naturally pr...
Walter Jeske,1 Jeanine M Walenga,1 Debra Hoppensteadt,2 Jawed Fareed2 1Cardiovascular Institute; 2De...
Abstract Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of ...
Abstract Biologicals are distinct from small molecule drugs in that they are larger, more structural...