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.
2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions
Prateek Jain
Independent Consultant, Toronto, Canada
KEY POINTS
Ensure consistent quality of biologics by controlling the manufacturing process.
Rigorous clinical studies are required in patients to demonstrate safety and efficacy of biologics.
Post‐approval monitoring of safety and efficacy via pharmacovigilance plans need to be in place for of all prescribed biologics in patients to generate “real‐world” clinical data.
Abbreviations
| Abbreviation | Full name |
| ADA | Adenosine Deaminase Deficiency |
| ADC | Antibody–Drug Conjugate |
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| BPCIA | Biologics Price Competition and Innovation Act |
| CBER | Center for Biologics Evaluation and Research |
| CDE | Center for Drug Evaluation |
| CDER | Center for Drug Evaluation and Research |
| CFDA | China Food and Drug Administration |