PMID- 26983015
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181202
IS  - 1421-9875 (Electronic)
IS  - 0257-2753 (Linking)
VI  - 34
IP  - 1-2
DP  - 2016
TI  - Anti-TNFs: Originators and Biosimilars.
PG  - 132-9
LID - 10.1159/000443128 [doi]
AB  - In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFalpha) 
      biologics has revolutionized the treatment of patients with inflammatory bowel 
      disease (IBD) but the cost of biologic therapy now constitutes a large proportion 
      of all healthcare expenditures. Patent expiration has sparked the healthcare 
      industry's interest in the production of biosimilar (BS) versions of first 
      generation biologics (originators [ORGs]) for market sharing. Having no access to 
      the production line of the ORG, the sponsor of a BS needs to develop his own 
      manufacturing process to produce a highly similar version of the reference 
      product. Similarity in structure, physicochemical properties, biologic activity, 
      efficacy and safety must be demonstrated by a comprehensive comparability 
      exercise that includes the most sensitive in vitro tests, models and clinical 
      condition with pre-defined equivalence margins. Extrapolation of indications, 
      inter-changeability and automatic substitution between BS and ORG depend on a 
      legal framework that varies between different agencies. It is not, therefore, 
      unexpected that marketing authorization by the European Medicines Agency and 
      other regulatory agencies (but not Health Canada) of CT-P13 (Remsima/Inflectra) 
      as infliximab (Remicade) BSs for IBD by indication extrapolation has led to 
      stormy discussions in the IBD community and beyond regarding the scientific 
      adequacy of this decision. However, as we now have to live with BSs, we hope that 
      the impeding automatic substitution in association with post-marketing 
      pharmacovigilance, full traceability, registries and new studies will settle the 
      controversy and will increase the confidence of physicians and patients. A 
      universally adopted legal framework should be implemented because, as expected, 
      the non-anti-TNFalpha BSs will be soon on the stage.
CI  - (c) 2016 S. Karger AG, Basel.
FAU - Mantzaris, Gerassimos J
AU  - Mantzaris GJ
AD  - Department of Gastroenterology, 'Evangelismos' Hospital, Athens, Greece.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20160316
PL  - Switzerland
TA  - Dig Dis
JT  - Digestive diseases (Basel, Switzerland)
JID - 8701186
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Biosimilar Pharmaceuticals/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Health Personnel
MH  - Humans
MH  - Inflammatory Bowel Diseases/drug therapy
MH  - Product Surveillance, Postmarketing
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors/metabolism
EDAT- 2016/03/17 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/03/17 06:00
PHST- 2016/03/17 06:00 [entrez]
PHST- 2016/03/17 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 000443128 [pii]
AID - 10.1159/000443128 [doi]
PST - ppublish
SO  - Dig Dis. 2016;34(1-2):132-9. doi: 10.1159/000443128. Epub 2016 Mar 16.