Antibody biosimilars: Fears or opportunities? First LabEx MAbImprove industrial workshop, May 28, 2013 Tours, France

mAbs

Volumn 6, Issue 4, 2014, Pages 805-809

  Guillon Munos, Audrey ^a,b   Daguet, Arnaud ^a,b   Watier, Hervé ^a,b,c  

^a UNIVERSITÉ DE TOURS   (France)

^b CNRS   (France)

^c UNIVERSITY HOSPITAL OF TOURS   (France)

Author keywords

Biopharmaceuticals; Biosimilars; Regulatory issues; Societal issues; Therapeutic antibodies

Indexed keywords

ANTIBODY; BIOSIMILAR AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY;

BIOEQUIVALENCE; BIOTECHNOLOGY; CONFERENCE PAPER; DRUG DESIGN; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SCREENING; QUALITY CONTROL; ANIMAL; ECONOMICS; EDUCATION; FRANCE; HUMAN; ORGANIZATION;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; CONGRESSES AS TOPIC; EDUCATION; FRANCE; HUMANS;

EID: 84903618038     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.28831     Document Type: Conference Paper

References (6)

1. Antibody biosimilars: fears or opportunities? http://antibodybiosimilars. fr/en/index.html
2. Laboratoire d'Excellence MAbImprove http://mabimprove.univ-tours.fr/? lang=en
3. EMA guidelines on Biosimilars. http//www.ema.europa.eu/ema/index.jsp? curl=pages/regulation/general/general content 000408.jsp
4. Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29:310-2; PMID:21478841; http://dx.doi.org/10.1038/nbt.1839
5. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Ureña S, Lim M, Lee YA, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72:1605-12; PMID:23687259; http://dx.doi.org/10.1136/annrheumdis-2012-203091
6. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72:1613-20; PMID:23687260; http://dx.doi.org/10.1136/annrheumdis-2012-203090