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Ten Years of Biosimilars in Europe

BLOG CATEGORIES

JACOB F. SIEGEL | ARON FISCHER


DECEMBER 8, 2015

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

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Epoteins

FDA GUIDANCE DOCUMENTS

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

OTHER BLOGS & MICROSITES

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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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

Market adoption of biosimilars


Unlike generic small-molecule drugs, which generally replace brand-name
drugs once they are approved, adoption of biosimilars in the EU has been
mixed, ranging greatly between countries and between products. This is
because while the authorization to market biosimilars is provided centrally by
the EMA, each country retains control over substitution policies, i.e.
recommendations as to whether a biosimilar should be used interchangeably
with its reference medicine. Thus, for example, a recent study by the IMS
Institute for Healthcare Informatics found that biosimilar penetration in 2013
for G-CSF (filgrastim) ranged from 2% of treatment days in Belgium to nearly
100% in Croatia, Czech Republic, Hungary, and Romania. The IMS study
attributes di erences in the uptake of biosimilarsand di erences in price
competitionto local practices, practices in turn influenced by national
funding schemes and the actions of payers.

Product Specific Guidelines


The EMA has established specific guidelines detailing requirements for
regulatory approval for each of the categories of biosimilars currently
approved, as well as for biosimilar products containing interferon alpha,
interferon beta and low-molecular-weight heparins. Category-based guidelines
are valuable in the development of standards for biologics, since the
complexity of structure and glycosylation di ers greatly across categories of
biologic products. In the next several years, as the FDA considers applications
for biosimilars of varying types, we can expect that the U.S. will begin to
develop category-specific policies as well.

Naming schemes for biosimilars


In Europe, biosimilars are generally referred to by their trade names, which are

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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.

The next several years:


The U.S. has taken a more cautious pace to the approval of biosimilar
medications than the EU took in its first few years. While the U.S. biosimilar
statute became law in 2010 and the FDAs first guidance on biosimilars was
released in 2012, to date only one product (Zarxio) has been approved in the
U.S. as a biosimilar. The number of biosimilar applications pending FDA review
indicates that the next several years may be a time of rapid development in the
regulation of U.S. biosimilars although the FDAs most recent publicly
announced decision, rejecting Hospiras application for a biosimilar version of
Amgens Epogen (EPO), suggests that the FDA is taking a cautious approach
and will not approve a proposed biosimilar even when it is already marketed in
the EU. It remains to be seen to what extent the U.S. regulatory pathway
follows the contours of the European model.
BIOSIMILARS, BPCIA, LEGISLATION

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Aron Fischer
PARTNER
212-336-2363
AFISCHER@PBWT.COM

Jacob F. Siegel
ASSOCIATE
212-336-2335
JFSIEGEL@PBWT.COM

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