Biologics, Biosimilars, and Biobetters. Группа авторов

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Biologics, Biosimilars, and Biobetters - Группа авторов

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Wechsler, J. (2018). Biosimilars raise manufacturing and regulatory challenges. Pharm Technol 42 (7): 14–15.

      52 52 Gamez‐Belmonte, R., Hernandez‐Chirlaque, C., Arredondo‐Amador, M. et al. (2018). Biosimilars: concepts and controversies. Pharmacol Res 133: 251–264.

      53 53 Ramanan, S. and Grampp, G. (2014). Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 28 (4): 363–372.

      54 54 Declerck, P., Farouk‐Rezk, M., and Rudd, P.M. (2016). Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res 33 (2): 261–268.

      55 55 Rathore, A. (2009). Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol 27 (9): 546–553.

      56 56 Mitragotri, S., Burke, P., and Langer, R. (2014). Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies. Nat Rev Drug Discov 13 (9): 655–672.

      57 57 Hooven, M.D. (2017). Opportunities and challenges in biologic drug delivery. American Pharmaceutical Review. https://www.americanpharmaceuticalreview.com/Featured‐Articles/345540‐Opportunities‐and‐Challenges‐in‐Biologic‐Drug‐Delivery (accessed 20 February 2020).

      58 58 Kuhlmann, M. and Schmidt, A. (2014). Production and manufacturing of biosimilar insulins: implications for patients, physicians, and health care systems. Biosimilars 4: 45–58. https://doi.org/10.2147/BS.S36043.

      59 59 Jordan, B. (2019). U.S. biologics and biosimilars need distinguishable names. Stat News. https://www.statnews.com/2019/04/23/biologics‐biosimilars‐distinguishable‐names (accessed 20 February 2020).

      60 60 DiGrande, S. (2018). Australian Government announces decision on biosimilar naming conventions. The Center for Biosimilars. https://www.centerforbiosimilars.com/news/australian‐government‐announces‐decision‐on‐biosimilar‐naming‐conventions (accessed 20 February 2020).

      61 61 U.S. Food and Drug Administration (2020). Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. https://www.fda.gov/drugs/therapeutic‐biologics‐applications‐bla/purple‐book‐lists‐licensed‐biological‐products‐reference‐product‐exclusivity‐and‐biosimilarity‐or (accessed 18 June 2020).

      62 62 EGA (2010). Biosimilars handbook. https://www.medicinesforeurope.com/wp‐content/uploads/2016/03/EGA_BIOSIMILARS_handbook_en.pdf (accessed 20 February 2020).

      63 63 GaBi (2020). About GaBi journal. http://gabi‐journal.net/gabi‐journal/about‐gabi‐journal (accessed 18 June 2020).

      64 64 FDA (2016). Implementation of the Biologics Price Competition and Innovation Act of 2009. https://www.fda.gov/drugs/guidance‐compliance‐regulatory‐information/implementation‐biologics‐price‐competition‐and‐innovation‐act‐2009 (accessed 20 February 2020).

      65 65 Kabir, E.R., Moreino, S.S., and Sharif Siam, M.K. (2019). The breakthrough of biosimilars: a twist in the narrative of biological therapy. Biomolecules 9 (9): 410. http://dx.doi.org/10.3390/biom9090410.

      66 66 FDA (2018). FDA's Biosimilar Action Plan (BAP): balancing innovation and competition. https://www.fda.gov/media/114574/download (accessed 20 February 2020).

      67 67 NHS England (2017). Commissioning framework for biological medicines (including biosimilar medicines). https://www.england.nhs.uk/wp‐content/uploads/2017/09/biosimilar‐medicines‐commissioning‐framework.pdf (accessed 20 February 2020).

      68 68 Robinson, J. (2018). Preparing for the big biologic switch. Pharm J 301 (7916) https://doi.org/10.1211/PJ.2018.20205278.

      69 69 PrescQIPP (2019). We are an NHS funded not‐for‐profit organisation that supports quality, optimised prescribing for patients. https://www.prescqipp.info (accessed 20 February 2020).

      70 70 ABPI (2015). ABPI position on biologic medicines, including biosimilar medicines. https://www.abpi.org.uk/media/4568/abpi‐position‐on‐biosimilar‐medicines.pdf (accessed 20 February 2020).

      71 71 Healthcare Improvement Scotland (2018). Biosimilar medicines: a national prescribing framework. http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/biosimilar_medicines_framework.aspx (accessed 20 February 2020).

      72 72 National Institute for Health and Care Excellence (2016). NICE's biosimilars position statement. https://www.nice.org.uk/Media/Default/About/what‐we‐do/NICE‐guidance/NICE‐technology‐appraisals/Biosimilar‐medicines‐postition‐statement‐aug‐16.pdf (accessed 20 February 2020).

      73 73 National Institute for Health and Care Excellence (2016). Biosimilar medicines. https://www.nice.org.uk/advice/ktt15/resources/biosimilar‐medicines‐58757954414533 (accessed 20 February 2020).

      74 74 The Department of Health (2015). Biosimilar awareness initiative. Australian Government. https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar‐awareness‐initiative (accessed 20 February 2020).

      75 75 Ward, M., Lange, S., and Staff, K. (2016). Biosimilars awareness inititiative literature review. Australian Government. http://www.health.gov.au/internet/main/publishing.nsf/Content/biosimilar‐literature‐review (accessed 20 February 2020).

      76 76 chf.org.au (2016). Biologic and biosimilar medicines 2020: making the most of the opportunities. https://chf.org.au/sites/default/files/biologic_and_biosimilar_medicines_2020_making_the_most_of_the_opportunit.pdf

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