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References

Оглавление

1 1 https://www.researchgate.net/publication/228730641_Biosimilars_An_overview (accessed 20 September 2019).

2 2 https://researchadvocacy.org/sites/default/files/resources/Biosimilar%20Medicines6_4Final.pdf (accessed 20 September 2019); World Health Organization. Biological Qualifier: An INN Proposal.

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4 4 Programme on International Nonproprietary Names (INN). Revised draft July 2014. http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf (accessed 20 September 2019).

5 5 European Medicines Agency. Product‐Information Requirements. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000199.jsp; https://www.ema.europa.eu/en/documents/leaflet/biological‐medicinal‐products_en.pdf (accessed 20 September 2019).

6 6 https://www.pmda.go.jp/files/000152369.pdf; https://www.ema.europa.eu/en/human‐regulatory/research‐development/scientific‐guidelines/biological‐guidelines (accessed 20 September 2019).

7 7 https://www.tga.gov.au/publication/australian‐regulatory‐guidelines‐biologicals‐argb; https://www.tga.gov.au/regulatory‐framework‐biologicals (accessed 20 September 2019).

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9 9 https://www.iqvia.com//media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf (accessed 20 September 2019).

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18 18 https://www.amgenbiotech.com/manufacturing‐innovation.html; https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life‐sciences‐health‐care/us‐lshc‐advanced‐biopharmaceutical‐manufacturing‐white‐paper‐051515.pdf; https://www.bio.live/visit/news‐and‐updates/biologics‐driving‐innovation‐drug‐packaging‐and‐devices (accessed 20 September 2019).

19 19 https://www.iqvia.com/‐/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf; https://www.pharmaceutical‐journal.com/news‐and‐analysis/features/making‐drugs‐work‐better‐four‐new‐drug‐deliverynbspmethods/20203530.article?firstPass=false; https://fortune.com/2017/05/03/drug‐delivery‐breakthroughs (accessed 20 September 2019).

20 20 QuintilesIMS White paper: cell & gene therapies: innovation to commercialisation – can industry bridge the gap? Published QI 2015; FDA. Implementation of the Biologics Price Competition and Innovation Act of 2009. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215089.htm (accessed 20 September 2019).

21 21 QI MIDAS Q4 2015, Pharmerging markets only – Pharmerging markets defined as a group of 21 emerging countries adding US$1 billion of cumulative pharmaceutical growth over the next five years.

22 22 FDA (2019). Considerations in Demonstrating Interchangeability with a Reference Product, Guidance (May 2019); FDA. From Our Perspective: Biosimilar Product Labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm (accessed 20 September 2019).

23 23 https://www.mabxience.com/blogs/differences‐between‐substitution‐and‐interchangeability; https://www.biopharma‐reporter.com/Article/2017/03/21/Biosimilr‐switching‐interchangeability‐and‐substitution‐the‐EU‐view; https://safebiologics.org/wp‐content/uploads/2016/04/AUS‐Onepager‐Substitution‐FNLe.pdf; https://www.amgenbiosimilars.com/bioengage/prescribing‐biosimilars/substitution‐and‐interchangeability (accessed 20 September 2019).

24 24 https://www.mckinsey.com/industries/pharmaceuticals‐and‐medical‐products/our‐insights/whats‐next‐for‐biosimilars‐in‐emerging‐markets; https://www.beroeinc.com/whitepaper/biosimilars‐emerging‐markets (accessed 20 September 2019).

25 25 https://www.thebalance.com/top‐biologic‐drugs‐2663233 (accessed 20 September 2019); QI MIDAS Q4 2015, Pharmerging markets only – Pharmerging markets defined as a group of 21 emerging countries adding US$1 billion of cumulative pharmaceutical growth over the next five years.

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