[HTML][HTML] Commercial low molecular weight heparins—patent ecosystem and technology paradigm for quality characterization
Z Iqbal, S Sadaf - Journal of Pharmaceutical Innovation, 2023 - Springer
… heparin) are losing market exclusivity worldwide, inviting the generic/biosimilar drug … (GAG)
of animal origin having weight-average molecular weight (M w ) of ~ 12,000 Da …
of animal origin having weight-average molecular weight (M w ) of ~ 12,000 Da …
Quality control, safety assessment and preparation approaches of low molecular weight heparin
Y Yu, Y Song, Y Zhao, N Wang, B Wei, RJ Linhardt… - Carbohydrate …, 2024 - Elsevier
… highly purified heparin lyase of bacterial origin., Heparin lyase … Recently, various patents for
low molecular weight heparin … , leading to generic or biosimilar products that capture market …
low molecular weight heparin … , leading to generic or biosimilar products that capture market …
Comparative studies on the anticoagulant profile of branded enoxaparin and a new biosimilar version
…, LB Agati, F Siddiqui, A Kouta… - Clinical and Applied …, 2020 - journals.sagepub.com
… Background Enoxaparin is the most widely used low molecular weight heparin (LMWH)
worldwide. Several biosimilar versions of Lovenox (enoxaparin sodium; Sanofi, Paris, France), …
worldwide. Several biosimilar versions of Lovenox (enoxaparin sodium; Sanofi, Paris, France), …
Biosimilars and Identification of Biosimilarity
U Malairaman - 2021 - ir.juit.ac.in
… are developed by complex biological background. There are … drug and biosimilar.[8] Approval
of enoxaparin in July 2010, which is a generic heparin drug with low molecular weight, this …
of enoxaparin in July 2010, which is a generic heparin drug with low molecular weight, this …
[HTML][HTML] Approaches to assure similarity between pharmaceutical heparins from two different manufacturers
FF Bezerra, SN Oliveira, RA Sales, AA Piquet… - Pharmaceutics, 2023 - mdpi.com
… of heparin preparations, as well as identify the tissue of origin. … followed for low-molecular-weight
heparins, which we … of low-molecular-weight heparin for molecular weight calibration”. …
heparins, which we … of low-molecular-weight heparin for molecular weight calibration”. …
An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare
F Mascarenhas-Melo, M Diaz, MBS Gonçalves… - Pharmaceuticals, 2024 - mdpi.com
… Generics are chemically synthesized small molecules, which … is then possible to determine
the molecular mass accurately. If we … , we can achieve 100% coverage of the sequence. This …
the molecular mass accurately. If we … , we can achieve 100% coverage of the sequence. This …
[HTML][HTML] A Regulatory Perspective on Biosimilar Medicines
MA Cordeiro, C Vitorino, C Sinogas, JJ Sousa - Pharmaceutics, 2024 - mdpi.com
… of high molecular weight with high complexity and are … Formulary and, when this is not
mentioned, that period should … some biosimilars, such as low-molecular-weight heparins obtained …
mentioned, that period should … some biosimilars, such as low-molecular-weight heparins obtained …
Biosimilars: a comparative study of regulatory, safety and pharmacovigilance monograph in the developed and developing economies
Z Iqbal, S Sadaf - Journal of Pharmacy & Pharmaceutical …, 2022 - journals.library.ualberta.ca
… number and the country of origin may be used for distinction. … coverage in favor of biosimilars
counterparts ▪ Subjecting … , FDA had approved low molecular weight heparin – Levonox- …
counterparts ▪ Subjecting … , FDA had approved low molecular weight heparin – Levonox- …
The landscape of biosimilars in Saudi Arabia: preparing for the next decade
AR Almutairi, AM Al-Samil, A Alsayyari… - Expert Opinion on …, 2023 - Taylor & Francis
… as well as wholesale price in the country of origin in its local currency; 5) the proposed …
drug evaluation is necessary prior to addition. The process of biosimilar addition to a formulary …
drug evaluation is necessary prior to addition. The process of biosimilar addition to a formulary …
[图书][B] Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars-getting decisions right
P Cornes, A McBride - 2020 - books.google.com
… biosimilars are relatively recent additions to the formulary. … The first difference is size: for
example, the molecular mass of … of small molecule drugs drove down prices, biosimilars can …
example, the molecular mass of … of small molecule drugs drove down prices, biosimilars can …