Biosimilars: current status and future directions.
BACKGROUND
Expiration of patents covering biopharmaceuticals, has provided opportunities for pharmaceutical companies to develop, produce and market biosimilars or follow-on biologicals. However, there have been concerns over the degree of similarity of these complex drugs in addition to the hope that their introduction may lower the cost of such expensive medicinal products.


METHODS
The introduction/manufacturing considerations, immunogenicity and regulatory approaches to biosimilars around the world. In addition, arguments and techniques employed by pharmaceutical companies to advance or discredit biosimilar drugs will be outlined. Issues with post-marketing surveillance programmes and their limitations are described.


RESULTS
This evaluation outlines the controversial issues associated with introduction of biosimilar medicines across a range of pharmacological indications. Also the differences between regulatory approved medicines and biopharmaceutical products not subjected to regulatory approval ('B-NSRA') are highlighted. The review is limited by the rapid changes in regulatory approval and licencing of biosimilars.


CONCLUSIONS
Hopefully biosimilar medicines will allow more widespread availability of expensive biopharmaceutical products. Clinicians need to be wary of non-transparent promotion of innovator/biosimilar products.
Roger
Simon D
SD
Renal Unit, Gosford Hospital, Holden Street, Gosford, 2250, NSW, Australia. sroger@nsccahs.health.nsw.gov.au
D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000096:biosynthesis / Q000737:chemistry / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D001709:Biotechnology / Q000639:trends*; D003257:Consumer Product Safety; D017277:Drug Approval; D016527:Drug Costs; D006297:Health Services Accessibility; D006801:Humans; D010330:Patents as Topic; D011487:Protein Conformation; D011994:Recombinant Proteins / Q000009:adverse effects / Q000096:biosynthesis / Q000737:chemistry / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D018570:Risk Assessment; D013329:Structure-Activity Relationship; D016896:Treatment Outcome
D001688:Biological Products; D011994:Recombinant Proteins