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A biosimilar is a copy of an antibody drug made by a different company in different cells. It cannot be identical, so the maker must prove the copy behaves the same in the laboratory and in patients. Biosimilars of trastuzumab, bevacizumab and rituximab have cut the cost of these drugs sharply.
Because a biologic is defined by its process, a biosimilar developer starts from scratch: it builds a new CHO cell line expressing the same amino acid sequence, develops a process whose glycan pattern, charge variants, aggregates and potency fall within the range of many lots of the reference product, and runs analytical, pharmacokinetic and usually one comparative clinical trial. The EU approved the first biosimilar in 2006 and the first oncology antibody biosimilars in 2017; the FDA approved Zarxio (filgrastim, Sandoz) in 2015 as the first US biosimilar, Mvasi (bevacizumab, Amgen) and Ogivri (trastuzumab, Mylan and Biocon) in 2017, and Truxima (rituximab, Celltrion) in 2018. Several biosimilars of each now compete, made by Celltrion in Incheon, Samsung Bioepis, Amgen, Pfizer, Sandoz, Biocon in Bengaluru, Dr Reddy's and Intas among others.
Manufacturing is where the value lies: the same CHO culture, Protein A purification and fill-finish chain as the originator, run by companies competing on cost of goods, so biosimilar makers were early adopters of high-titre processes and single-use plants. Regulators police them with the same GMP inspections and with comparability rules (ICH Q5E) whenever a process changes. Uptake is high in Europe and rising in the United States; in low- and middle-income countries biosimilar trastuzumab is often the only affordable route to HER2-directed therapy.
Reverse engineering of an antibody's quality attributes to within the reference product's range, proved by analytical similarity and confirmatory clinical data.
Query for this technology: (TITLE:"Biosimilar manufacturing and comparability" OR ABSTRACT:"Biosimilar manufacturing and comparability") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Biosimilar manufacturing and comparability, not a curated reading list.
Shares Sandoz, Intas Pharmaceuticals (Accord Healthcare), Viatris, Dr. Reddy's Laboratories and the tag manufacturing-wave.
Shares Sandoz, Intas Pharmaceuticals (Accord Healthcare), Viatris, Dr. Reddy's Laboratories and the tag manufacturing-wave.
Shares Antibody manufacturing (CHO bioprocessing), Sterile fill-finish and lyophilisation, GMP, inspections, Form 483s and warning letters, Downstream purification (Protein A capture, viral clearance, polishing) and the tag manufacturing-wave.
Shares Antibody manufacturing (CHO bioprocessing), Downstream purification (Protein A capture, viral clearance, polishing) and the tag manufacturing-wave.
Shares Dr. Reddy's Laboratories, GMP, inspections, Form 483s and warning letters, Prices and value and the tag manufacturing-wave.
Shares Antibody manufacturing (CHO bioprocessing), Downstream purification (Protein A capture, viral clearance, polishing) and the tag manufacturing-wave.
Shares GMP, inspections, Form 483s and warning letters, Prices and value and the tag manufacturing-wave.
Shares Sterile fill-finish and lyophilisation and the tag manufacturing-wave.