Biologics, Biosimilars, and Biobetters. Группа авторов

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High‐Performance Liquid Chromatography IBD Inflammatory Bowel Disease ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use INN International Non‐proprietary Name IP Intellectual Property LDN Limited Distribution Network LMWH Low Molecular Weight Heparins MA Marketing Authorisation MAA Marketing Authorisation Application MCOs Managed Care Organisations MR Mutual Recognition NHS National Health Service NDA New Drug Application NMS Non‐Medical Switching NICE National Institute for Clinical Excellence (UK) mAb Monoclonal Antibody PBAC Pharmaceutical Benefits Advisory Committee PBS Pharmaceutical Benefits Scheme PFS Pre‐Filled Syringe PHS Public Health Service PMS Post‐Marketing Surveillance PPRS Pharmaceutical Price Regulation Scheme (UK) QbD Quality by Design RCT Randomised Clinical Trial REMS Risk Evaluation and Mitigation Strategies RMOCs Regional Medicines Optimisation Committees (UK) RMPs Risk Management Plans RMR Reaction Monitoring Report RPG Reference Price Group RWD Real‐World Data SB Synthetic Biology SEBs Subsequent‐Entry Biologics SBPs Similar Biotherapeutic products SMDs Small molecule Drugs SmPAR Summary of Pharmacovigilance Assessment Report SmPc Summary of Product Characteristics SPBs Similar Protein Biotherapies TGA Therapeutic Goods Administration TPP Target Product Profile TPQP Target Product Quality Profile WHO‐UMC World Health Organization‐Uppsala Monitoring Centre

      The subsequent chapters of this book are pitched explicitly to pharmacists and doctors and deal in greater detail with the various scientific, clinical, economic, QUM, and pharmacovigilance aspects of innovator biologics, biosimilars, and biobetters. The material provided in this and subsequent chapters should facilitate discussions by pharmacists with doctors and patients on these expensive and highly effective medicines so that the full therapeutic potential of all biologic medicines is realized in a timely manner.

Acknowledgement

      The author thanks Dr Reza Kahlaee for expert assistance with collation of the cited references.

References

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      7 7 Beyer, B., Walch, N., Jungbauer, A., and Lingg, N. (2019). How similar is biosimilar? A comparison of infliximab therapeutics in regard to charge variant profile and antigen binding affinity. Biotechnol J 14 (4): e1800340.

      8 8 Nick, C. (2015). Quality attributes in the making and breaking of biosimilarity. Regul Rapporteur 12 (9): 10–13.

      9 9 Dahodwala, H. and Sharfstein, S.T. (2017). Biosimilars: imitation games. ACS Med Chem Lett 8 (7): 690–693.

      10 10 Zhang, A., Tzeng, J.‐Y., and Chow, S.‐C. (2013). Statistical considerations in biosimilar assessment using biosimilarity index. J Bioequivalence Bioavailab 5 (5): 209–214.

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