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http://www.biologicsblog.com/blog/ten-years-of-biosimilars-in-europe/
The Biologics Law Blog of Patterson Belknap Webb & Tyler LLP
PBWT.COM
BLOG CATEGORIES
BY DATE
This fall marks the tenth anniversary of the e ective date of the European
Medicines Agencys Guideline on Similar Biological Medicinal Products. As this
blog noted previously, the EUs biosimilar pathway both preceded the U.S.
pathway created in 2010 and came into use more quickly. Over the past ten
years, the EMA has approved 19 biosimilars under the guidelines,
corresponding to 6 di erent reference drugs, in six categories of biologics:
epoetins, filgrastims, follitropins, growth hormones, insulins, and monoclonal
antibodies. The EMAs Committee for Medicinal Products for Human Use
recently recommended granting marketing authorization for a biosimilar of
Enbrel, a dimeric fusion protein, which would constitute a seventh category.
Although the U.S., with its larger and more homogenous pharmaceutical
market, is unlikely to follow the exact same path as Europe, the European
experience is relevant in assessing the future of biosimilars in the United States.
Biosimilar Products Approved by the EMA as of December 7, 2015 (1)
Biosimilar
Trade Name
Marketer
Active
Substance
Reference
Drug
Year of
Approval
BIOBETTERS
BIOSIMILARS
BIOTECHNOLOGY
BPCIA
EMA
FDA
LABELING
LEGISLATION
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STATUTES AND LEGISLATIVE HISTORY
Epoteins
Abseamed
Medice
epoetin alfa
Eprex/Erypo
2007
Binocrit
Sandoz
epotein alfa
Eprex/Erypo
2007
Epoetin Alfa
Hexal
Hexal
epotein alfa
Eprex/Erypo
2007
Retacrit (2)
Hospira
epotein zeta
Eprex/Erypo
2007
Silapo
Stada
epotein zeta
Eprex/Erypo
2007
Accofil
Accord
filgrastim
Neupogen
2014
Biograstim
AbZ-Pharma
filgrastim
Neupogen
2008
Filgrastim
Hexal
Hexal
filgrastim
Neupogen
2009
Grastofil
Apotex
filgrastim
Neupogen
2013
Nivestim
Hospira
filgrastim
Neupogen
2010
Ratiograstim
Ratiopharm
filgrastim
Neupogen
2008
Tevagrastim
Teva
filgrastim
Neupogen
2008
Zarzio (3)
Sandoz
filgrastim
Neupogen
2009
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11/14/2016 9:24 AM
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Biosimilar
Trade Name
Marketer
http://www.biologicsblog.com/blog/ten-years-of-biosimilars-in-europe/
Active
Substance
Reference
Drug
Year of
Approval
Follitropins
Bemfola
Finox
follitropin
alfa
GONAL-f
2014
Ovaleap
Teva
follitropin
alfa
GONAL-f
2013
Sandoz
somatropin
Genotropin
2006
Eli Lilly
insulin
glargine
Lantus
2014
Inflectra
Hospira
infliximab
Remicade
2013
Remsima
Celltrion
infliximab
Remicade
2013
Growth
Hormones
Omnitrope (4)
Insulins
Abasaglar (5)
Monoclonal
Antibodies
(1) Two additional biosimilars were approved by the EMA but subsequently had their authorizations
withdrawn.
(2) BPCIA application to market in the United States rejected by the FDA
(3) Approved in the United States as a biosimilar under the BPCIA with trade name Zarxio
(4) Approved in the United States under the 505(b)(2) pathway
(5) Original EU trade name was Abasria; tentatively approved in U.S. under 505(b)(2) pathway with
trade name Basaglar
11/14/2016 9:24 AM
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http://www.biologicsblog.com/blog/ten-years-of-biosimilars-in-europe/
di erent from those of the brand-name reference drug, but the non-proprietary
names of European biosimilars are identical to those of their reference drug.
For instance, the European packaging for Zarzio (the European trade name for
Zarxio) identifies the product by that trade name and by its International
Nonproprietary Names name, filgrastim. Filgrastim is the same INN name used
for the reference product, Neupogen, even though the two products are
(bio)similar rather than identical. The FDAs recently issued dra guidance, by
contrast, requires the addition of a randomly-assigned su ix for all biologic
products. It results in di erent non-proprietary names for biosimilars and their
reference drugs. Under the proposed U.S. naming scheme, for example, Zarxio
will be identified as filgrastim-bflm, while Neupogen will be assigned the
name filgrastim-jcwp.
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PARTNER
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AFISCHER@PBWT.COM
Jacob F. Siegel
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212-336-2335
JFSIEGEL@PBWT.COM
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