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Key Sandoz Biosimilar Publications
Schiestl M et al. Acceptable changes in quality attributes of glycosylated biopharmaceutical. Nature Biotechnology (2011) 29:310-312.
Lamanna WC et al. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opinion in Biological Therapy (2018) 18:369-379.
Cohen HP et al. Switching reference medicines to biosimilars: A systematic literature review of clinical outcomes. Drugs (2018) 78:463-478.
Cohen HP. Approval of biosimilar medicines through totality of evidence. Drug Development and Delivery. (2019) 19:40-45.
Cohen HP et al. The Importance of Countering Biosimilar Disparagement and Misinformation. BioDrugs (2020) 34:407-414.
Griffiths CEM et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Brit J Derm (2017) 176;928-938.
Gascon P et al. Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study). Support Care Cancer (2016) 24:911-925.
Blauvelt A et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Brit J Derm (2018) 179:623-631.
Jeremias, S. Filgrastim Agent Is Cost-Effective in NSCLC, According to ASCO Study. Center for Biosimilars. May 31, 2020.
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Switching from a Reference Biologic to a Biosimilar
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