The document discusses key differences between the biosimilar markets in the EU and US. The EU approved its first biosimilar, Omnitrope, in 2006 and has since approved over 48 biosimilars, while the US approved its first, Zarxio, in 2015 and has approved only 11. The disparity is due to differences in regulatory pathways, interchangeability standards, and litigation procedures. The EU has a more established pathway under the EMA and allows for interchangeability through physician switching or pharmacist substitution, while the US pathway was only established in 2009 and has stricter interchangeability requirements. Patent litigation is also more complex and drawn out in the US compared to the centralized process in Europe.

1. Regulatory Affairs in Science PHAR40240
Dr. Craig Slattery
University College Dublin
May 09, 2019
Assignment done by,
Malavika Sankararaman (18200405)
ACROSS THE GREAT DIVIDE –
WHY ARE EU AND US BIOSIMILAR
MARKETS SO DIFFERENT?

2. 1
Assessment Submission Form
Student Name Malavika Sankararaman
Student Number 18200405
Assessment Title
Across the Great Divide – Why are EU and US market so different?
(Topic – 4)
Module Code PHAR40240
Module Title Regulatory Affairs in Science
Module Co-ordinator Dr. Craig Slattery
Tutor (if applicable)
Date Submitted May 09, 2019
Date Received
Grade/Mark
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clear acknowledgement and appropriate reference to the work of others.
SIGNATURE
DATE May 10, 2019

3. 2
1. INTRODUCTION
Across the globe, economic hurdles and the complexity surrounding the regulatory process are
molding the differences in the Biosimilar industry. From authorizing its first Biosimilar in
2006, to approving over 48 products until 2018, Europe has become the leading hotspot for
biosimilar products. This is followed by the US, which approved its first biosimilar in 2015,
almost a decade after EU and until 2018, had authorized only 11 biosimilars, out of which only
3 have been launched in the market. Globally, 87% of the biosimilar sales occur in Europe,
whereas US constitutes only for 2%. This disparity is due to the key differences in the
regulatory pathway, interchangeability, and litigation procedures between the two regions
(boehringer-ingelheim.us, 2018).
This report will be using case studies to understand the mentioned differences, will derive a
summary as to why US is lagging behind EU and will conclude by quoting the required actions
to be taken.
Fig 1: Biosimilar sales in EU and US (boehringer-ingelheim.us, 2018)
2. THE DIFFERENCE
i. Timeline of Biosimilar Guidelines: Europe & US
Biosimilars in Europe, go through a centralised procedure of authorization, under the CHMP
(Committee for Human Medicinal Products) wing of EMA (European Medicines Agency) and
get licensed by the European Commission, based on the report submitted by EMA. To tackle
the unknown factors in the approval process, the EMA issued product specific guidelines on
clinical, non-clinical and quality topics, in 2003, and formed an abbreviated pathway in 2004.
This led to the approval of Sandoz’s Omnitrope, Europe’s first biosimilar, in 2006.
On the other hand, in US, Biosimilar applications are filed under an abbreviated pathway
through the Biologics License Application (BLA), formed as a part of the Biologics Price
Competition and Innovation Act of 2009 (BPCIA) and are approved by the Food & Drug
Administration (FDA). Upon the formation of BPCIA, it took United States, 3 years to release

4. 3
its first guidance documents, following which, in 2015, US approved its first biosimilar,
Sandoz’s Zarxio (filgrastim) (Ayad K. et al, 2018)
Fig 2: Biosimilar timeline of EU and US (Ayad K. et al, 2018)
Case of Omnitrope
Sensing the patent expiration of the first recombinant human growth hormone, the EMA
prepared frameworks, and guidelines to monitor the safety, efficiency and quality of biosimilar
drugs, in the year 2005. Thus, within a year of implementing this general regulatory guideline,
the EMA approved its first biosimilar, a human growth hormone product – Omnitrope,
developed by Sandoz, in 2006 (Saenger et al, 2017). Approval of Omnitrope, a biosimilar of
Pfizer’s Genotropin, portrays a swift and well-codified system of the EU (biologicsblog.com,
2015)(pharmatimes.com, 2006).
In USA, Sandoz had filed for license under section 505(b)(2), in the year 2003, and after
waiting for 1000 odd days, the firm sued FDA in 2005, for not taking a call within the 180-
days review period. Upon persuasion by the federal court, in 2006, FDA approved Omnitrope
as a follow-on biologic, and not as a biosimilar (fdanews.com, 2006).
This depicts FDA’s reluctance in expanding the biologic product portfolio and the slow
implementation process of the United States.
ii. Regulatory Pathway – 351(k) vs. 505(b)(2)
Case of Insulin Biosimilars
There is a vast difference in the approval guidelines between the two regions (dcatvi.org, 2018).
Under the BPCIA act, FDA is limited to approve biosimilars that have been made from

5. 4
biologics, authorized as per the section 351(k) of the Public Health Service Act. This restricts
the FDA to approve biosimilars made from small molecules, such as Insulin and hormone
drugs, since they were authorized via 505(b)(1) regulatory pathway, called as the New Drug
Application. Nevertheless, in 2014, FDA tentatively approved an insulin analog developed by
Eli Lilly – Basaglar, as a follow-on biologic, to Lantus by Sanofi, under the 505(b)(2) pathway
(biosimilarresourcecenter.org, 2015). Follow-on biologics are not favored by manufacturers,
due to the Hatch-Waxman protocol, under which, within 45 days of notification, the originator
can sue the biosimilar company, resulting in a 30-month waiting period for approval (MaryII
et al, 2015). In Basaglar’s case, Sanofi sued Eli Lilly, alleging that four of its patents had been
violated, thus obtaining time for Sanofi to launch its very own follow-on in the market. Finally,
after settling the legal battle, Basaglar was launched across US, in 2016 (White et al, 2019).
Fig 3: Differences between 351(k) and 505(b)(2) (biologicsblog.com, 2015)
A new guidance, is being developed by the FDA to address this issue, as per which, simple
protein drugs, licensed under the 505(b)(1) pathway, will be added to the BLAs, upon its
implementation, in the year 2020. However, this document does not talk about the existing
small molecule drugs approved under the same pathway, such as the reference product of Eli
Lilly’s Basaglar. During the transition period, the pending applications would have to be
resubmitted, which would take a toll on the sponsor companies. Also, the manufacturers are
not sure whether to submit a BLA, due to inadequate information, and are hesitating to go
through a 505(b)(2) process, owing to its longer approval time, thus creating a “blackout
period” for the pharmaceutical industry (raps.org, 2016). Apart from this disadvantage, this
long-awaited move will be beneficial for both biosimilar manufacturers and the people, since
it would address the alarming increase in the insulin prices, by an average of 17%, every year
(biopharma-reporter.com, 2018).

6. 5
Conversely, the EU regulatory pathway, includes all type of protein products under the
category of biological medicines, thus paving the way for Europe, to approve its first Insulin
biosimilar – Abasaglar (Eli Lilly), in 2014. Comparatively, this depicts the unclarified
regulatory pathway of the US.
Fig 4: The approval pathway of Eli Lilly’s Basaglar, outlining the two different licensing
paths for biosimilars in the US (Rosenstock et al., 2015)
iii. Patent Litigations
In the US, under the BPCIA act, the applicant and the originator can engage in a “patent dance”,
a shortened litigation strategy, that enables voluntary exchange of information. In Europe, the
most common method, is for the biosimilar manufacturer to challenge the originator’s patent,
in a European Patent Office (EPO), which provides a decision, valid across 38 contracting
states. Though time consuming, this low-cost method, considers patent thickets as a single
lawsuit (europeanpharmaceuticalreview.com, 2016)(Malkin, B.J et al, 2015).
Sandoz vs. Amgen
After filing aBLA for filgrastim, Sandoz chose not to patent dance, by not providing its
manufacturing procedure to the reference company – Amgen. In return, Amgen sued Sandoz
for patent infringement, and for market notification, prior to FDA licensure. Upon being ruled
out by the Federal court, Sandoz appealed at the supreme court, which favored the firm, by
concluding that, upon the completion of 12-year exclusivity, the applicant can choose to by-
pass the patent dance and may also release marketing notice before FDA approval. The case
delayed Sandoz market launch by 6-months, which cost the US, $45million/month
(blog.jipel.nyu.edu, 2018)(specialtypharmacytimes.com, 2015).

7. 6
Fig 5: Patent dance followed by US (patentdocs.org, 2019)
AbbVie & Amgen
In 2017, Amgen and AbbVie reached for a settlement, as per which, Amgen agreed not to
launch its biosimilar version of Humira (adalimumab), a popular biologic produced by AbbVie,
until 2018 in Europe and 2023, in US. In return, Amgen would secure the patent for usage and
selling of adalimumab from AbbVie.
Such agreements help reference companies to extend their market exclusivity, while it saves
biosimilar manufacturers, from costly patent lawsuits and product launch delays
(bioworld.com). Moreover, AbbVie restricted competition by obtaining 136 patents around
Humira. The delay in launch of Amgen’s biosimilar has cost the US healthcare, $1.2billion.
The above cases depict, the cumbersome litigation strategies of the US, which are misused by
the originators to block biosimilar competition. Such anti-competitive strategies are being
restricted in the Europe, by setting up Anti-trust Investigations (ec.europa.eu, 2019).
In the US, a Biologic Patent Transparency Act, has been passed only in the March of 2019.
Under this act, a purple book would contain all patent exclusivity information about biologics,
thus a strategy to prevent lawsuits (fda.gov, 2018).
iv. Interchangeability
In Europe, interchangeability is defined under the consensus document of the EMA. Here,
interchangeability can either occur through product switching by the prescriber or through
substitution, by a pharmacist, without the intervention of the prescriber. However, EMA does
not take decisions on interchangeability. It is taken by the member states, based on their
healthcare policies. EU does not favor substitution since it may cause harm, but switching has
been actively spreading across Europe, with highest incidence occurring in the Central and
Eastern parts, to reduce costs and manage limited availability of the biologics. France, Italy,

8. 7
Denmark, and several other countries, have stated in favor of the EMA’s guidance,
that there is no need for any additional experiments, to support interchangeability
(O’Callaghan et al, 2018).
Fig 6: Additional clinical studies model required by the FDA to prove safe and efficient
switching of biosimilar (gabionline.net, 2018)
In the USA, interchangeability is covered by the BPCIA act. FDA has the authority to deem a
biosimilar as interchangeable. Accordingly, interchangeability can occur through substitution
by a pharmacist, without consulting the prescriber. Unlike Europe, FDA requires additional
clinical studies, involving 3 product switches, to accept interchangeability status
(gabionline.net, 2018). Upon this decision, each member state would be required to introduce
a legislation, to assist the pharmacist and the prescriber. In 2017, after the release of a draft
guideline on interchangeability by FDA, manufacturers have stated that they were not happy
with the additional transition studies, since it would be time consuming and cost an
extra $100-$200mn (pharmaceuticaltechnology.com, 2018).
NOR-Switch trial
NOR-SWITCH, a study funded by Norway, shows that switching from the biologic
(Infliximab) to a cost efficient biosimilar (CT-P13), will not compromise on the safety, and
efficacy of the treatment. Such studies may influence the acceptance of biosimilar switching,
across the US, without additional studies (Jørgensen et al, 2017).
Market uptake
Interchangeability impacts drug price reduction, and market uptake. As of 2017, there has been
27% price reduction across Europe, while only 3% rate decrease across US, primarily because,
until now, no biosimilar has been deemed as an interchangeable in US (Kawalec et al,
2017)(Mulcahy et al., 2018). Majority of the European countries and UK, have substantially
lowered the biologic/biosimilar prices, through an aggressive bidding process or through
negotiations with healthcare bodies (Moorkens et al, 2017). In contrast, owing to the slow
market uptake, US cannot practise tendering, since, massive discounts might reduce the return
on investment. The EU government directly sources and places the biosimilars in the market,
thereby preventing the need of Pharmacy Benefit Managers, who have been alleged
to hinder the market uptake in US, by accepting rebates from reference companies
(decisionresourcegroup.com, 2018).

9. 8
Fig 7: Chart created from the data obtained from (Kawalec et al, 2017), to represent the
price reduction between biologics and biosimilar
Nomenclature
Naming of a biosimilar, to an extent, influences the proper application of interchangeability.
EMA uses a simple naming system, based on WHO guidelines, wherein the biosimilar uses the
same non-proprietary Name (INN), as its reference product. Here, the product is distinguished
from the rest, by its brand name. US developed a guideline, in 2017, under which a biosimilar
is differentiated, by adding a random 4-letter suffix to the USAN (US Adopted Name).
a)
b)
Fig 8: a) Nomenclature followed in Europe b) Nomenclature followed in US
Evidence obtained from several manufacturers, outline that the procedure followed by Europe,
helps unequivocal prescription and a 96.2% easy identification across similar products
(medicinesforeurope.com, 2016). Meanwhile, the addition of suffix to the biosimilars in USA
45%
61%
71%
30% 30%
85%
0%
20%
40%
60%
80%
100%
Germany France Scandivanion
countries
Nordic
countries
UK US
Price reduction for biosimilars across Europe and U.S
Original drug price Biosimilar price

10. 9
may lead to major confusion among pharmacists, in terms of substitution. Conversely, data
taken from the EudraVigilance, suggest that, in 2017, 26% of the reported adverse events for
infliximab, was not identified by its brand name, thus hindering traceability (ema.europa.eu,
2017). US suggests that pharmacovigilance can be improved by its naming policy (Felix et al,
2019). Perhaps, this system could become efficient, if the suffix could avoid confusion, as in
the case of filgrastim-sndz, where the 4-letters, could be contemplated to its company - Sandoz.
3. CRITICAL INSIGHTS FROM EUROPE
Education has always been the key aspect, that makes Europe lead the biosimilar market. The
EC and EMA make sure that all the stakeholders (physicians, patients, manufacturers, insurers)
are well-informed about the regulatory guidelines, interchangeability status and the safety of
the biosimilars. EU substantially reduces biosimilar price through the practise of aggressive
bidding, thereby increasing market uptake. Europe may also influence the US market and
regulatory bodies to treat biosimilars as non-inferior to the biologics through its Government
funded studies. Europe practices a single-payer system, wherein the government regulates
biosimilar pricing, provides prescriber incentives and discounts, thus preventing anti-
competition incidences (Malkin, B.J et al, 2015). A report released by EC emphasizes that, if
by 2020, biosimilars occupy the market of 15 of the top 20 biologics, then healthcare costs can
be slashed by $113bn across EU and US (OECD/EU, 2018).
4. CONCLUSION
Being a relatively new market, the US can pace up to Europe, if it swiftly attends to the
following requirements:
 Define and concise regulatory framework
 Simplify the interchangeability guidelines
 Uncomplex naming system
 Create awareness among stakeholders
 Stringent strategies to control monopoly
Overall, both Europe and US need to address the immoral activities performed by top
companies such as AbbVie, to extend market exclusivity. If EU and US create an undemanding
and cost efficient regulatory pathway, and a consistent market uptake across all regions, then
biosimilar competition would increase, eventually resulting in an effective and affordable
healthcare system.

11. 10
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