Document Detail


Is the advent of biosimilars affecting the practice of nephrology and the safety of patients?
MedLine Citation:
PMID:  18451686     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Low-molecular-weight drugs are classical medicinal pharmaceutical products. Generic drugs are the chemical and therapeutic equivalent of low-molecular-weight drugs whose patent has expired. Biopharmaceuticals are medicinal products developed by means of biotechnological processes such as recombinant DNA, controlled gene expression, antibody methods. Biosimilar or similar biological medicinal products are those that are referenced to an existing product and submitted to regulatory authorities for marketing authorization by an independent applicant after the time of protection of the data has expired for the original product. The terms 'biogeneric', 'second entry biological', 'subsequent entry biological', 'non-patented biological product' and 'multisource product' have also been used for these substances but the EMEA (European Agency for the Evaluation of medicinal products) prefers the term 'biosimilar' (the FDA coined the term 'follow-on biologic'). For nephrologists, who are used to prescribing biopharmaceuticals such as erythropoietin to their patients, the issue of emerging biosimilars is of particular importance. Responsibility exists, therefore, at the highest level to review the safety profile of the biopharmaceutical products and the emerging biosimilar products in terms of efficacy, immunological response and tolerance.
Authors:
Claudio Ronco
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Contributions to nephrology     Volume:  161     ISSN:  0302-5144     ISO Abbreviation:  Contrib Nephrol     Publication Date:  2008  
Date Detail:
Created Date:  2008-05-02     Completed Date:  2008-07-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513582     Medline TA:  Contrib Nephrol     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  261-70     Citation Subset:  IM    
Affiliation:
Dipartimento Interaziendale ULSS4-5-6 di Nefrologia Dialisi e Trapianto Renale, Ospedale San Bortolo, Vicenza, Italy. claudio.ronco@ulssvicenza.it
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MeSH Terms
Descriptor/Qualifier:
Biological Products / adverse effects,  therapeutic use*
Drugs, Generic / adverse effects,  therapeutic use*
Erythropoietin, Recombinant / adverse effects,  therapeutic use*
Humans
Molecular Weight
Chemical
Reg. No./Substance:
0/Biological Products; 0/Drugs, Generic; 0/Erythropoietin, Recombinant

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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