title: Specific anti-IIa activity is a key indicator of safety and efficacy in validation of biosimilarity of unfractioned heparin preparations.
abstract: We compared anti-IIa activity of a heparin analogue and a reference product was carried out to confirm their biosimilarity. The experiment was based on the method of estimation of anti-IIa activity of a commercial sodium heparin preparation according to United States Pharmacopoeia. High similarity of the two medicinal heparin preparations by this parameter is shown. The method is recommended for the use in comparability studies.
authors.affiliation: Research Center for Evaluation of Medical Products, the Ministry of Health of the Russian Federation, Moscow, Russia.
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: D V
authors.initials: DV
authors.lastname: Goryachev
authors.forename: E V
authors.initials: EV
authors.lastname: Garvishina
authors.forename: R R
authors.initials: RR
authors.lastname: Niyazov
authors.forename: O Yu
authors.initials: OY
authors.lastname: Ivanova
mesh_terms: D000704:Analysis of Variance; D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D002417:Cattle; D002809:Chondroitin Sulfates / Q000009:adverse effects* / Q000737:chemistry; D004342:Drug Hypersensitivity / Q000378:metabolism*; D006493:Heparin / Q000032:analysis* / Q000494:pharmacology* / Q000592:standards; D011516:Prothrombin / Q000037:antagonists & inhibitors*; D012044:Regression Analysis; D012426:Russia; D013045:Species Specificity; D013552:Swine
chemical_list: D059451:Biosimilar Pharmaceuticals; D011516:Prothrombin; C025337:Factor IIa; D006493:Heparin; D002809:Chondroitin Sulfates