Global Biosimilars Pipeline Report Highlights: Global Biosimilars Market Overview Global Biosimilars Market Dynamics Regulatory Framework Across Key Markets Biosimilar Clinical Pipeline Insight by Indication, Country & Phase Marketed Biosimilars Profiles by Indication & Country Competitive Landscape

1. Global Biosimilars Market & Pipeline Insight 2018
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The evolution of biosimilars has currently reached different stages across the world. Owing to
variable clarity in the guidelines and diverse regulatory pathways diverse, various definitions
of biosimilars (or the broader group of follow-on biologics) have emerged across countries.
Till now the European region has the best-established framework for biosimilars. The USA is
currently almost aligned to the European standards. Biosimilars are also known as follow on
biologics in the US and subsequent entry biologics in Canada, are biologic products which are
approved in a country, which has an abbreviated approval process for biologic products which
references an originator biologic in the regulatory submission.
The global biosimilars market is categorized into monoclonal antibody biosimilars (mAbs),
insulins, interferons, erythropoetins, filgrastim, somatropin and follicle stimulating hormone
(FSH). Among the segments of the biosimilars market, the monoclonal antibodies (mAbs) and
insulin market would witness maximum growth, with these two segments accounting for a
dominant share of 46% of the total global biosimilars market by 2018. Additionally, with the
mAbs having one of the strongest R&D pipeline in the biologics market, it is expected that
many new next-generation technologies which would push mAb therapeutics into newer areas
such as solid tumours, cardiovascular and neurological disorders would be introduced into the
market.
Patent expiry and a favourable government regulation are some of the major drivers of the
biosimilars market. It is expected that by 2018, many leading brands would lose their patents.
Owing to these factors, the pharmaceutical companies have been attracted to this market
and of late there has been a significant increase in the issuance and implementation of
guidelines for biosimilars approval across the globe. Additionally, the pharma companies are
aiming to develop reference biological therapeutics, which is also driving the market
significantly.
Though the global biosimilars market is set for significant growth over the next decade, there
are many regulatory uncertainties which could likely impact the growth over the medium
term. The complex nature of the biological therapeutics would require a deeper analysis of
the traditional small-molecule generic market. Thus, the pharma companies would be
required to invest significant resources into this market, in order to strengthen their position.

2. Global Biosimilars Market & Pipeline Insight 2018
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“Global Biosimilars Market & Pipeline Insight 2018” by KuicK Research gives comprehensive
insight on the various biosimilars being developed for the treatment of multiple diseases.
Research report covers all the ongoing biosimilars being developed in various development
phases, indication and development countries.
Global Biosimilars Pipeline Report Highlights:
• Global Biosimilars Market Overview
• Global Biosimilars Market Dynamics
• Regulatory Framework Across Key Markets
• Biosimilar Clinical Pipeline Insight by Indication, Country & Phase
• Marketed Biosimilars Profiles by Indication & Country
• Competitive Landscape
Global Biosimilars Pipeline Report Findings:
• Number of Biosimilars in Clinical Phase: 305
• Marketed Biosimilars: 66
• Maximum Number of Biosimilars in Preclinical Phase: 73
• Global Biosimilars Market Growth (2013-2018): More than 25% CAGR
• Europe Dominates the Clinical Trial Development of Biosimilars
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3. Global Biosimilars Market & Pipeline Insight 2018
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Table of Contents
1. Global Biosimilars Market Outlook
1.1 Market Overview
1.2 Market Dynamics: Drivers, Challenges & Future Opportunities
1.3 Biosimilars in Clinical Development Phase
2. Guidelines for Development & Marketing of Biosimilars
2.1 US
2.2 Europe
2.3 Canada
2.4 South Korea
2.5 India
2.6 Japan
3. Global Biosimilars Clinical Pipeline Insight by Indication, Country & Phase
3.1 Phase Unknown
3.2 Research
3.3 Preclinical
3.4 Clinical
3.5 Phase 0
3.6 Phase I
3.7 Phase I/II
3.8 Phase II
3.9 Phase III
3.10 Preregistration

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3.11 Registered
4. Marketed Biosimilars by Indication & Country
5. Discontinued & Suspended Biosimilars Profiles by Indication, Country & Phase
5.1 No Development Reported
5.2 Discontinued
5.3 Suspended
6. Competitive Landscape
6.1 Actavis
6.2 Amgen
6.3 BioXpress Therapeutics
6.4 Boehringer Ingelheim
6.5 Biocon
6.6 Bio Sidus
6.7 Dong-A Pharmaceutical
6.8 Harvest Moon Pharmaceuticals
6.9 Inbiopro Solutions
6.10 Mylan
6.11 Sandoz International

5. Global Biosimilars Market & Pipeline Insight 2018
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List of Figures
Figure 1-1: Global Biosimilars Market (US$ Billion), 2013-2018
Figure 1-2: Global Biosimilar Market by Segment (%), 2018
Figure 1-3: Biosimilars Development by Clinical Phase (%), 2014
Figure 1-4: Biosimilars Development by Clinical Phase (Number of Drugs), 2014
Figure 1-5: Suspended & Discontinued Biosimilars in Clinical Phase (Number of Drugs), 2014
Figure 6-1: Biocon Biosimilars Pipeline
Figure 6-2: Harvest Moon Pharmaceuticals Biosimilars Pipeline
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