Complex molecules – current developments
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 2
Abstract
The pharmacological activity and toxicity of non-biological complex drugs (NBCDs) depends on their complex structure and composition. The regulatory approach leading to the registration of such drugs and their follow-on products, deemed ‘nanosimilars’, must be based on emerging scientific knowledge of NBCD properties determining their in vivo fate.
Authors and Affiliations
Gerrit Borchard
Biosimilarity in Latin America
The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these...
Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased ris...
Austria increases dialogue in order to involve physicians more with biosimilars
Comment on the GaBI Journal article titled The potential for doctors to contribute to biosimilar guidelines [1] and the GaBI Online article titled Dialogue needed to build confidence in biosimilars [2], both by GaBI Jour...
Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection
‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized...
Pharmacokinetics of antimicrobials in obese children
Introduction: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with childhood obesity can a...