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Celltrion files Remsima in the United States
Celltrion files Remsima in the United States:
Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar. This marks the first 351(k) biosimilar mAb application to be filed in the U.S.A. and the second application for a biosimilar to be filed through the US BPCIA.
World’s first biosimilar antibody is approved in Korea
celltrion Worlds first biosimilar antibody* is approved in Korea
South Korean biosimilar manufacturer Celltrion, today declared that, Korean Food and Drug Administration approved its first biosimilar monoclonal antibody, Remsima.
Remsima is a biosimilar version of Remicade, the blockbuster in Rheumatoid Arthitis (RA). Korean FDA approved the product in several indications including RA, ankylosing spondylitis, ulcerative colitis, psoriasis and Crohn’s disease.
http://www.biosimilarnews.com/worlds-first-biosimilar-antibody-is-approved-in-korea
The European Commission has approved the first copycat version of an antibody-based drug, clearing the way for increased competition for the makers of multi-billion dollar biotechnology drugs to treat complex diseases
Tuesday’s final green light for Inflectra – which was developed by South Korea’s Celltrion and will be marketed by U.S. company Hospira – had been expected following a European Medicines Agency recommendation in June.
Hospira said the drug for treating rheumatoid arthritis and some other conditions would be launched throughout Europe “at the earliest opportunity taking into account any relevant patent protection”.
Inflectra is a so-called biosimilar version of Johnson & Johnson and Merck & Co’s Remicade.
http://www.reuters.com/article/2013/09/10/celltrion-hospira-europe-idUSL5N0H620R20130910
remicade= infliximab
Infliximab (INN; trade name Remicade) is a monoclonal antibody against tumour necrosis factor alpha (TNF-α) used to treat autoimmune diseases. Remicade is marketed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) in the USA, Mitsubishi Tanabe Pharma in Japan, Xian Janssen in China, and Schering-Plough (now part of Merck & Co) elsewhere.[1] In 2013, two biosimilars were submitted for approval in Europe, by Hospiraand Celltrion Healthcare.[2]
Infliximab was approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Infliximab won its initial approval by the FDA for the treatment of Crohn’s disease in August 1998.[3]
Infliximab works by binding to TNF-α. TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction. In rheumatoid arthritis, infliximab seems to work by preventing TNF-α from binding to its receptor in the cell.
Infliximab is an artificial antibody. It was originally developed in mice as a mouse antibody. Because humans have immune reactions to mouse proteins, the mouse common domains were replaced with similar human antibody domains. Because the antibodies were produced from one cell grown into a clone of identical cells, it is called a monoclonal antibody. Furthermore, as a combination of mouse and human antibody amino acid sequences, it is called a chimeric monoclonal antibody.
Infliximab was developed by Junming Le and Jan Vilcek at New York University School of Medicine and developed by Centocor, (now Janssen Biotech, Inc.)[4]
In the United States, Infliximab can cost $19,000 to $22,000 a year per patient wholesale, according to Centocor.[5]
Other monoclonal antibodies targeting TNF-α are golimumab (Simponi), adalimumab(Humira), and certolizumab pegol (Cimzia). Etanercept also binds and inhibits the action of TNF-α, but is not a monoclonal antibody (it is instead a fusion of TNF-receptor and anantibody constant region).[6]
Infliximab is administered by intravenous infusion, typically at six- to eight-week intervals, at a clinic or hospital. It cannot be administered orally because the digestive system would destroy the drug.[7]
- “Remicade Becomes First Anti-TNF Biologic Therapy to Treat One Million Patients Worldwide” (Press release).Johnson & Johnson. November 6, 2007. Retrieved 2009-11-14.
- ^ George, John (June 28, 2013). “Billion-dollar biotech drug may soon have biosimilar competition”. Philadelphia Business Journal. Retrieved June 27, 2013.
- ^ “Infliximab Product Approval Information – Licensing Action”.Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 2009-11-14.
- ^ Knight DM, Trinh H, Le J et al. (November 1993). “Construction and initial characterization of a mouse-human chimeric anti-TNF antibody”. Mol. Immunol. 30 (16): 1443–53.doi:10.1016/0161-5890(93)90106-L. PMID 8232330.
- ^ “Priced out of pain relief; Insurers balk at high costs of promising new treatments”, Victoria Colliver, San Francisco Chronicle, May 8, 2007
- ^ Peppel, K; et al. (1991). “A tumor necrosis factor (TNF) receptor-IgG heavy chain chimeric protein as a bivalent antagonist of TNF activity”. J. Exp. Med. 174 (6): 1483–9.doi:10.1084/jem.174.6.1483. PMC 2119031.PMID 1660525.
- ^ Steinhilber, D; Schubert-Zsilavecz, M; Roth, HJ (2005). “Molekülstruktur und biologische Eigenschaften”. Medizinische Chemie (in German) (1 ed.). Stuttgart: Deutscher Apothekerverlag. p. 5. ISBN 3-7692-3483-9.
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