Linked Life Data

20077245

Source:http://linkedlifedata.com/resource/pubmed/id/20077245

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2010-1-15
pubmed:abstractText
Biosimilars are a new class of medicine. The European Medicines Agency has pioneered the legal, regulatory, and scientific framework for approval of these products. One of the foundational principles of the European framework is that biosimilars are expected to be similar, not identical, to the innovator biologics they seek to copy. This contrasts with the legal, regulatory, and scientific framework for copies of chemical medicines, generics, which are based on the expectation that the innovator and generic drug substance are identical. This article reviews the European biosimilar regulatory pathway and reviews some of the clinical data being made public following the approval, rejection, and withdrawal of biosimilar marketing applications.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1520-5711
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
20
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
3-9
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Biosimilar medicines--new challenges for a new class of medicine.
pubmed:affiliation
Regulatory Affairs CMC, Amgen, Inc., Thousand Oaks, California 91320-1799, USA. afox@amgen.com
pubmed:publicationType
Journal Article, Review