Q: with the development of biomedical technology, the definition of some academic concepts is getting more attention and more precise. The two pharmaceutical concepts of "similar biomedical products" and "generic pharmaceutical products" are difficult to distinguish in the current practice. Here, please explain the difference between the two? How do you think to correctly understand the connotation of the two and their practical significance in clinical application?
A: with the development of medicine and drug research, the development of new drugs is remarkable. But the huge investment of money and time in the development of new drugs has led to the launch of "generic pharmaceutical products". However, "similar biomedical products" are not "generic pharmaceutical products", and the guidelines for "similar biomedical products" published by the human pharmaceutical products council have clearly stated that similar biomedical products are not considered generic pharmaceutical products. In addition to the need for comparative studies to confirm their similar safety and efficacy, the products must be adequately characterized. This is even less likely to be the case with biological substances extracted from biological sources than with highly purified, biotechnology-derived products.
Enoxaparin, commonly used in the anticoagulation field, is a biomedical product made from biogenic material porcine heparin. Currently enoxaparin cannot be characterized solely by physical-chemical experiments, and its properties depend on physical-chemical and biological experiments as well as a combination of production methods and controls. It has been confirmed that enoxaparin 1, 6-dehydrating ring structure and other structure fingerprints may be the basis of its pharmacological and clinical characteristics.
In addition, in accordance with heparin by not only interact with antithrombin III effect (accounts for 20-30%), and can be controlled by the release of tissue factor pathway inhibitor (TFPI), auxiliary factor II with heparin (HC) II interaction, inhibitory effect of white blood cells to promote blood clotting, promote fibrinolysis, protein and regulating vascular endothelial function of pathways. These data confirm that traditional LMWH markers such as the anti-xa/anti-iia ratio cannot fully characterize the overall pharmacological activity of enoxanin-like LMWHs. Therefore, a standard simplified marketing license application based solely on the statement that a product is a statement in the generic form of a reference product is not sufficient for a biomedical product, stating that an application for an "enoxa-like" product must include appropriate preclinical and clinical trial results.
The European council, the FDA, the American college of cardiology, the European society of cardiology and other authorities have come to the conclusion that different biologic products are not interchangeable. It is suggested that in clinical drug selection, it should be kept in mind that generic products should not be considered to have the same pharmacological activity, efficacy and safety simply because they claim to have the same molecular weight, anti-factor Xa or anti-factor IIa activity, and/or anti-factor Xa/ anti-factor IIa ratio as enoxanheparin. At present, kexai ® is applied in 126 countries in the world, accounting for 60% of the low-molecular weight heparin class. However, the precision of pharmaceutical academic concept in China still needs to be further studied and improved, so I think it is necessary to raise the awareness of more clinicians.