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References
Оглавление1 1 Davies, N. (2018). The future of biologics. Pharm Lett www.thepharmaletter.com/article/the‐future‐of‐biologics (accessed 20 June 2020).
2 2 Sarpatwari, A., Barenie, R., Curfman, G. et al. (2019). The US biosimilar market: stunted growth and possible reforms. Clin Pharmacol Ther 105 (1): 92–100.
3 3 Dutta, B., Huys, I., Vulto, A.G., and Simoens, S. (2019). Identifying key benefits in European off‐patent biologics and biosimilar markets: it is not only about price! BioDrugs 34 (Suppl. 3): 159–170. https://doi.org/10.1007/s40259‐019‐00395‐w.
4 4 Johnson, I. (1983). Human insulin from recombinant DNA technology. Science 219 (4585): 632–637.
5 5 WHO (2009). Health Organization expert committee on biological standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). https://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1 (accessed 17 February 2020).
6 6 Declerck, P. and Farouk, R.M. (2017). The road from development to approval: evaluating the body of evidence to confirm biosimilarity. Rheumatology (Oxford) 56 (suppl 4): iv4–iv13.
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.
11 11 Beck, A. and Reichert, J.M. (2013). Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs 5 (5): 621–623.
12 12 Mehr, S.R. and Zimmerman, M.P. (2016). Is a biologic produced 15 years ago a biosimilar of itself today? Am Health Drug Benefits 9 (9): 515–518.
13 13 Webster, C.J. and Woollett, G.R. (2017). A ‘global reference' comparator for biosimilar development. BioDrugs 31 (4): 279–286.
14 14 Diependaele, L., Cockbain, J., and Sterckx, S. (2018). Similar or the same? Why biosimilars are not the solution. J Law Med Ethics 46 (3): 776–790.
15 15 Pani, L., Montilla, S., Pimpinella, G., and Bertini, M.R. (2013). Biosimilars: the paradox of sharing the same pharmacological action without full chemical identity. Expert Opin Biol Ther 13 (10): 1343–1346.
16 16 Blanchard, A., D'Iorio, H., and Ford, R. (2010). What you need to know to succeed: key trends in Canada’s biotech industry. Insight 1 (Spring).
17 17 Mechcatie, E. (2010). FDA asks: when are biosimilars similar enough? Commun Oncol 8 (10): 479–480.
18 18 Murphy, C., Sugrue, K., Mohamad, G. et al. (2015). P505: biosimilar but not the same. Paper presented at 10th Congress of ECCO2015, Barcelona, Spain (January 2015).
19 19 Vijayalakshmi, R., Sabitha, K., and Arvind, K. (2012). How dissimilarly similar are biosimilars? Int Res J Pharm 3 (5): 12–16.
20 20 Ronco, C. (2005). Biosimilars: how similar are they? Int J Artif Organs 28 (6): 552–553.
21 21 Jeffrey, K. and Ferner, R. (2016). How similar are biosimilars? BMJ Online 353: i2721.
22 22 Gupta, P. (2017). Biosimilars: similar but not the same. JK Sci 19 (2): 67–69.
23 23 Dingermann, T. and Zündorf, I. (2007). Biosimilars: similar, but not the same. Dtsch Apoth Ztg 147 (38): 68–74.
24 24 Dingermann, T. and Zündorf, I. (2015). Same, similar or different? How biosimilars can differ from originals. Dtsch Apoth Ztg 155 (7).
25 25 Schellekens, H. (2004). How similar do ‘biosimilars' need to be? Nat Biotechnol 22 (11): 1357–1359.
26 26 Schellekens, H. and Moors, E. (2015). Biosimilars or semi‐similars? Nat Biotechnol 33 (1): 19–20.
27 27 Rudolf, T., Brinkmann, C., and Bleiziffer, A. (2015). Biosimilars‐necessary alternative or overpriced me‐toos? Pharm Ind 77 (2): 160–165.
28 28 Rolf, D., Parker, J., and Morgan, M. (2016). Are biosimilars patentable? Expert Opin Ther Pat 26 (8): 871–875.
29 29 Guillon‐Munos, A., Daguet, A., and Watier, H. (2014). Antibody biosimilars: fears or opportunities? First LabEx MabImprove Workshop. MAbs 6 (4): 805–809.
30 30 Declerck, P., Danesi, R., Petersel, D., and Jacobs, I. (2017). The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs 77 (6): 671–677.
31 31 Courtois, F., Schneider, C.P., Agrawal, N.J., and Trout, B.L. (2015). Rational design of biobetters with enhanced stability. J Pharm Sci 104 (8): 2433–2440.
32 32 Ebbers, H.C., Crow, S.A., Vulto, A.G., and Schellekens, H. (2012). Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 30 (12): 1186–1190.
33 33 Esplugues, J.V., Flamion, B., and Puig, L. (2016). Putting the “bio” in “biotherapeutics”/checkpoints for biosimilars/application of biosimilars. New Horiz Transl Med 3 (3–4): 161.
34 34 Moots, R., Azevedo, V., Coindreau, J.L. et al. (2017). Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep 19 (6): 37.
35 35 Biologics Prescribers Collaborative (BPC) (2018). Non‐Medical Switching Principles and Guidelines (16 March). www.biologicsprescribers.org/policy‐issues/non‐medical‐switching (accessed 20 June 2020).
36 36 French, T. (2018). Shared decision making in switching to biosimilars. Ann Rheum Dis 77 (Supplement 2): 7.
37 37 Cvancarova S.M., Brandvold, M., and Andenaes, R. (2018). Is patients' satisfaction with being switched to a biosimilar medication associated with their level of health literacy? Results from a Norwegian user survey. Ann Rheum Dis 77 (Supplement 2): 86.
38 38 McKinnon, R.A., Cook, M., Liauw, W. et al. (2018). Biosimilarity and interchangeability: principles and evidence. A systematic review. BioDrugs 32 (1): 27–52.
39 39 GaBi Online (2018). International policies for interchangeability, switching and substitution of biosimilars. http://gabionline.net/Reports/International‐policies‐for‐interchangeability‐switching‐and‐substitution‐of‐biosimilars (accessed 18 February 2020).
40 40 Milmo, S. (2016). Biosimilars: making the switch comes with challenges. More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars. BioPharm Int 29 (6): 10–14.
41 41 Uhlig, T. and Goll, G.L. (2017). Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford) 56 (Suppl 4): iv49–iv62.
42 42 Gerrard, T.L., Johnston, G., and Gaugh, D.R. (2015). Biosimilars: extrapolation of clinical use to other indications. GaBI J 4 (3): 118–124.
43 43 McCamish, M. and Woollett, G. (2017). Molecular “sameness” is the key guiding principle for extrapolation to multiple indications. Clin Pharmacol Ther 101 (5): 603–605.
44 44 Pouillon, L., Socha, M., Demore, B. et al. (2018). The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol 14 (9): 739–749.
45 45 Povsic, M., Lavelle, P., Enstone, A., and Rousseau, B. (2018). Patient influence on biosimilar uptake: the nocebo effect. Value Health 21 (Supplement 3): S181.
46 46 Buttel, I.C., Chamberlain, P., Chowers, Y. et al. (2011). Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 39 (2): 100–109.
47 47 Strand, V., Goncalves, J., Hickling, T.P. et al. (2018). Immunogenicity of biosimilars for rheumatic diseases: an updated review from regulatory documents and confirmatory clinical trials. Ann Rheum Dis 77 (Supplement 2): 1398.
48 48 World Health Organization, CIOMS (2018). Definitions. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/trainingcourses/definitions.pdf (accessed 20 February 2020).
49 49 European Medicines Agency (2014). Guideline on similar biological medicinal products containing biotechnology‐derived proteins as active substance: non‐clinical and clinical issues. https://www.ema.europa.eu/en/documents/scientific‐guideline/guideline‐similar‐biological‐medicinal‐products‐containing‐biotechnology‐derived‐proteins‐active_en‐2.pdf (accessed 20 February 2020).
50 50 Calvo, B., Martinez‐Gorostiaga, J., and Echevarria, E. (2018). The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation. Ther Adv Drug Saf 9 (10): 601–608.
51 51 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 (accessed 16 June 2020).
77 77 Sherman, R.E., Anderson, S.A., Dal Pan, G.J. et al. (2016). Real‐world evidence: what is it and what can it tell us? N Engl J Med 375 (23): 2293–2297.
78 78 Ronnebaum, S. and Atzinger, C. (2018). Enhancing biosimilar adoption with real‐world evidence. Value & Outcomes Spotlight July/August: 26–28.
79 79 Zheng, L. (2018). Shall we (patent) dance? Key considerations for biosimilar applicants. https://www.biosimilardevelopment.com/doc/shall‐we‐patent‐dance‐key‐considerations‐for‐biosimilar‐applicants‐0001 (accessed 18 February 2020).
80 80 Ohly, C. and Patel, S.K. (2011). Evergreening biologics. J Gene Med 8 (3): 132–139.
81 81 Karas, L., Shermock, K.M., Proctor, C. et al. (2018). Limited distribution networks stifle competition in the generic and biosimilar drug industries. Am J Manag Care 24 (4): e122–e127.
82 82 Dranitsaris, G., Jacobs, I., Kirchhoff, C. et al. (2017). Drug tendering: drug supply and shortage implications for the uptake of biosimilars. Clinicoecon Outcomes Res 9: 573–584.
83 83 Vogenberg, F. and Gomes, J. (2014). The changing roles of P&T Committees: a look back at the last decade and a look forward to 2020. P&T 39 (11): 760–772.
84 84 The Department of Health (2019). Quality use of medicines (QUM). https://www1.health.gov.au/internet/main/publishing.nsf/Content/nmp‐quality.htm‐copy2 (accessed 20 February 2020).
85 85 Papathanasiou, P., Brassart, L., Blake, P. et al. (2016). Transparency in drug regulation: public assessment reports in Europe and Australia. Drug Discov Today 21 (11): 1806–1813.