Drug tendering: drug supply and shortage implications for the uptake of biosimilars

Figures & data

Table 1 Patent-expiration dates of biologics and development status for some biosimilars^64,86–93

Biologic	US patent expiration	Biosimilar status	EU patent expiration	Biosimilar status
Filgrastim	2013	Approved	2006	Approved
Epoetin-α	2015	Application filed	2004	Approved
Pegfilgrastim	2015	Application filed	2015	Application filed
Adalimumab	2016	Approved	2018	Approved
Rituximab	2018	Phase III trials	2013	Approved
Infliximab	2018	Approved	2015	Approved
Trastuzumab	2019	Application filed	2014	Application filed
Bevacizumab	2019	Application filed	2018	Application filed
Etanercept	2028/2029	Approved	2015	Approved

Notes: Expiration dates are based on those cited within Genetic Engineering & Biotechnology News,⁸⁸ although other patent dates may apply; there is no patent that specifically claims the composition of matter of cetuximab.

Table 2 Biosimilar availability in Canada, Europe, and the US^63,64,94

Reference product	Indication	Biosimilar	Manufacturer	Date of licensing/authorization
Canada
Insulin glargine (Lantus^®)	Diabetes mellitus	Basaglar^®	Eli Lilly Canada	September 1, 2014
Etanercept (Enbrel^®)	Ankylosing spondylitis Rheumatoid arthritis	Brenzys^®	Merck Canada	August 31, 2016
Filgrastim (Neupogen^®)	Neutropenia	Grastofil^®	Apotex	December 7, 2015
Somatropin (Genotropin^®)	Growth-hormone deficiency in adults and children	Omnitrope^®	Sandoz	April 20, 2009
Infliximab (Remicade^®)	Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis	Inflectra^®	Hospira	January 15, 2014
	Ankylosing spondylitis Psoriatic arthritis Psoriasis Rheumatoid arthritis	Remsima^®	Celltrion	January 15, 2014
Europe
Insulin glargine (Lantus^®)	Diabetes mellitus	Abasaglar^®	Lilly del Caribe Eli Lily	September 9, 2014
		Lusduna^®	Merck Sharp & Dohme	January 4, 2017
Somatropin (Genotropin^®)	Dwarfism Pituitary Prader–Willi syndrome Turner syndrome	Omnitrope^®	Sandoz	April 12, 2006
Filgrastim (Neupogen^®)	Neutropenia	Accofil^® Grastofil^®	Intas Pharmaceuticals Intas Pharmaceuticals	September 18, 2014 October 18, 2013
	Cancer	Nivestim^®	Hospira Zagreb	June 8, 2010
	Hematopoietic stem-cell transplantation	Ratiograstim^® Tevagrastim^® Zarzio^®	Sicor Biotech Sicor Biotech Sandoz	September 15, 2008 September 15, 2008 February 6, 2009
	Neutropenia	Filgrastim Hexal^®	Sandoz	February 6, 2009
Epoetin-α (Eprex^®/Erypo^®)	Anemia Cancer Chronic kidney failure	Abseamed^®	Rentschler Biotechnologie; Lek Pharmaceuticals	August 28, 2007
	Anemia Chronic kidney failure	Binocrit^®	Rentschler Biotechnologie; Lek Pharmaceuticals	August 28, 2007
	Anemia Cancer Chronic kidney failure	Epoetin Alfa Hexal^®	Rentschler Biotechnologie; Lek Pharmaceuticals	August 28, 2007
	Anemia Autologous blood transfusion Cancer Chronic kidney failure	Retacrit^® Silapo^®	Norbitec GmbH Norbitec GmbH	December 18, 2007 December 18, 2007
Follitropin alfa (GONAL-f^®)	Anovulation	Bemfola^® Ovaleap^®	Polymun Scientific Immunbiologische Forschung Merckle Biotec	March 27, 2014 September 27, 2013
Etanercept (Enbrel^®)	Psoriatic arthritis Rheumatoid arthritis Psoriasis	Benepali^®	Biogen (Denmark) Manufacturing	January 14, 2016
Infliximab (Remicade^®)	Psoriatic arthritis Rheumatoid arthritis	Flixabi^®	Biogen (Denmark) Manufacturing	May 26, 2016
	Ulcerative colitis Crohn’s disease Psoriasis Ankylosing spondylitis	Inflectra^® Remsima^®	Celltrion Celltrion	September 10, 2013 September 10, 2013
Enoxaparin sodium (Clexane^®)	Venous thromboembolism	Inhixa^® Thorinane^®	Techdow Europe Pharmathen	September 15, 2016 September 15, 2016
United States
Adalimumab (Humira^®)	Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Crohn’s disease Psoriasis Ankylosing spondylitis	Amjevita^®	Amgen	September 23, 2016
Etanercept (Enbrel^®)	Psoriatic arthritis Rheumatoid arthritis Psoriasis Ankylosing spondylitis	Erelzi^®	Sandoz	August 30, 2016
Filgrastim (Neupogen^®)	Cancer Hematopoietic stem-cell transplantation Neutropenia	Zarxio^®	Sandoz	March 6, 2015
Infliximab (Remicade^®)	Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Crohn’s disease Psoriasis Ankylosing spondylitis	Inflectra^®	Celltrion	April 5, 2016

Notes: Availability as of February 28, 2017.

US Food and Drug AdministrationCenter for Drug Evaluation and Research: list of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date2016 Available from: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdfAccessed September 8, 2017

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