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Pharma Leader Series: 25 Top Biosimilar
Drug Manufacturers 2016-2026
and Other Rising Companies a Market Report Assessing
Developers and Producers of Those Competitor Biologics

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Contents
1. Report Overview
1.1 Overview of the Top Biosimilar Drug Manufacturers
1.2 Why You Should Read This Report
1.3 How This Report Delivers
1.4 Main Questions Answered by This Analytical Study
1.5 Who is This Report For?
1.6 Methodology
1.7 Frequently Asked Questions (FAQ)
1.8 Associated Visiongain Reports
1.9 About Visiongain
2. Biosimilar Drugs: World Market Forecast, 2016-2026
2.1 Introduction to Biologics and Biosimilars
2.1.1 Biologic Drugs Definition and Overview
2.1.2 Biosimilars Drugs Definition and Overview
2.1.3 How do Biosimilars Differ from Generics?
2.2 The World Biosimilar Market, 2015-2026
2.3 Overall World Biosimilars Revenue Forecast, 2016-2026
2.4 Biosimilars – Realising their Potential, Market Drivers
2.4.1 Biosimilar Approval Pathways and Regulations
2.4.2 Emerging Markets for Biosimilars
2.4.3 Start-up Pressure on Market Leaders
2.4.4 The Patent Cliff for Biologics
2.5 Biosimilars: Market Restraints

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Contents
2.5.1 Market Fragmentation for Biosimilar Products
2.5.2 Innovative Biologics – Rendering Biosimilars Useless?
2.5.3 Biobetters – A Growing Threat
3. Leading Biosimilar Products: Overview, 2016
3.1 Humira: Product Overview
3.1.1 Adalimumab Biosimilars – Zydus Cadila
3.1.2 Adalimumab Biosimilars – Amgen-Actavis
3.1.3 Adalimumab Biosimilars – Sandoz
3.1.4 Adalimumab Biosimilars – Momenta Pharmaceuticals
3.1.5 Adalimumab Biosimilars – Pfizer
3.1.6 Adalimumab Biosimilars – Boehringer Ingelheim
3.2 Remicade: Product Overview
3.2.1 Infliximab Biosimilar – Epirus Pharmaceuticals & Ranbaxy
3.2.2 Infliximab Biosimilar – Celltrion & Hospira & Alvogen
3.3 Enbrel: Product Overview
3.3.1 Etanercept Biosimilar – Cipla & Shanghai CP Guojian
3.3.2 Etanercept Biosimilar – Daiichi Sankyo & Coherus Biosciences
3.4 Aranesp: Product Overview
3.4.1 Darbepoetin Alpha Biosimilar – Dr. Reddy’s Laboratories
3.4.2 Darbepoetin Alpha Biosimilar – Cipla & Hetero Drugs Limited
3.4.3 Darbepoetin Alpha Biosimilar – Hospira
3.5 Rituxan: Product Overview
3.5.1 Rituximab Biosimilar – Sandoz

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Contents
3.5.2 Rituximab Biosimilar – Amgen
3.5.3 Rituximab Biosimilar – Boehringer Ingelheim
3.5.4 Rituximab Biosimilar – Dr. Reddy’s Laboratories
3.5.5 Rituximab Biosimilar – Pfizer
3.5.6 Rituximab Biosimilar – Difficulties Seen in Trials
4. Leading Biosimilar Manufacturers in the United States, Western
Europe and Israel, 2016
4.1 Sandoz – Company Overview & Analysis
4.1.1 Sandoz Biosimilar Products
4.1.2 Sandoz Biosimilars Market Forecast, 2016-2026
4.1.3 Sandoz Biosimilars R&D Pipeline & Future Outlook
4.1.3.1 GP2017 – Adalimumab Biosimilar
4.1.3.2 GP2015 – Etanercept Biosimilar
4.1.3.3 GP2013 – Rituximab Biosimilar
4.1.3.4 HX575 – Epoetin-alfa Biosimilar
4.1.3.5 EP2006 – Zarzio (Filgrastim Biosimilar)
4.2 Teva Pharmaceuticals – Company Overview & Analysis
4.2.1 Teva Biosimilar Products
4.2.2 Teva Biosimilar Market Forecast, 2016-2026
4.2.3 Teva Biosimilar Pipeline & Future Outlook
4.3 Hospira – Company Overview & Analysis
4.3.1 Hospira Biosimilar Products
4.3.2 Hospira Biosimilars Pipeline & Future Strategies

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Contents
4.3.2.1 Retacrit
4.3.2.2 Celltrion Partnerships
4.3.2.3 NovaQuest Partnership
4.4 STADA Arzneimittel – Company Overview & Analysis
4.4.1 STADA Biosimilar Products
4.4.2 STADA Biosimilars Pipeline & Future Outlook
4.4.2.1 Biosimilar Pegfilgrastim
4.4.2.2 Biosimilar Rituximab
4.4.2.3 Biosimilar Teriparatide
4.5 Mylan – Company Biosimilar & Analysis
4.5.1 Mylan Biosimilar Products
4.5.2 Mylan Biosimilar Market Forecast, 2016-2026
4.5.3 Mylan Biosimilars Pipeline & Future Outlook
4.5.3.1 Mylan and Momenta - Biosimilars Product Development Programme
4.5.3.2 Biosimilar Insulin Glargine
4.5.3.3 A Series of Biosimilar Monoclonal Antibodies
4.5.3.4 Biosimilar Insulin Lispro & Aspart
4.6 Other Biosimilars Companies in the US
4.6.1 Impax Laboratories Inc. – Company Overview & Analysis
4.6.2 Bristol-Myers Squibb – Company Overview & Analysis
4.6.3 Merck & Co. – Company Overview & Analysis
4.6.4 Eli Lilly - Company Overview & Analysis
4.7 Other Biosimilars Companies in Europe
4.7.1 BioXpress Therapeutics – Company Overview & Analysis

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Contents
4.7.2 Medice Arzneimittel Pütter GmbH & Co. KG – Company Overview & Analysis
4.7.3 Finox Biotech – Company Overview & Analysis
4.7.4 Actavis – Company Overview & Analysis
5. Leading Biosimilar Manufacturers in China, 2016
5.1 S3Bio – Company Overview & Analysis
5.1.1 3SBio Biosimilar Products
5.1.2 3SBio Biosimilars Market Forecast, 2016-2026
5.1.3 3SBio Biosimilars Pipeline & Future Outlook
5.1.3.1 Second-generation rhEPO products
5.1.3.2 Nadroparin Calcium
5.2 Qilu Pharmaceutical – Company Overview & Analysis
5.2.1 Qilu Pharmaceutical Biosimilar Products
5.2.2 Qilu Pharmaceutical Biosimilars Pipeline & Future Outlook
5.2.2.1 Extensive Pipeline Developments
5.2.2.2 Etanercept Biosimilar
5.2.2.3 Other Biosimilars in Pipeline
5.3 Shanghai Fosun Pharmaceuticals – Company Overview & Analysis
5.3.1 Shanghai Fosun Pharmaceuticals Biosimilar Products
5.3.2 Shanghai Fosun Pharmaceuticals Biosimilars Pipeline & Future Strategy
5.3.2.1 Trastuzumab Biosimilar
5.3.2.2 Rituximab Biosimilar
5.3.2.3 Acquisitions and Investments
5.4 Tonghua Dongbao – Company Overview & Analysis

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Contents
5.4.1 Tonghua Dongbao Biosimilar Products
5.4.2 Tonghua Dongbao Biosimilars Pipeline & Future Strategies
5.4.2.1 Biosimilar Insulin Analogues
5.4.2.2 Investments in New Production Plant
5.5 Beijing ShuangLu Pharmaceuticals – Company Overview & Analysis
5.5.1 Beijing ShuangLu Pharmaceuticals Biosimilar Products
5.5.2 Beijing ShuangLu Pharmaceutical Biosimilars Pipeline & Future Outlook
5.6 Other Biosimilars Companies in China
5.6.1 Shanghai CP Guojian – Company Overview & Analysis
5.6.2 Zhejiang Hisun – Company Overview & Analysis
5.6.3 Innovent Biologics – Company Overview & Analysis
5.6.4 Shanghai Celgen Biopharmaceutical – Company Overview & Analysis
6. Leading Biosimilar Manufacturers in India, 2016
6.1 Biocon – Company Overview & Analysis
6.1.1 Biocon Biosimilar Products
6.1.2 Biocon Biosimilars Market Forecast, 2016-2026
6.1.3 Biocon Biosimilars Pipeline & Future Outlook
6.1.3.1 Biosimilar Bevacizumab
6.1.3.2 Biosimilar Adalimumab
6.1.3.3 Biosimilar Pegfilgrastim
6.1.3.4 Biosimilar Trastuzumab
6.1.3.5 Biosimilar Etanercept
6.1.3.6 Biosimilar Recombinant Human Insulin
6.1.3.7 Biosimilar Insulin Glargine

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Contents
6.1.3.8 Other Biosimilar Insulin
6.2 Dr. Reddy’s Laboratories – Company Overview & Analysis
6.2.1 Dr. Reddy’s Laboratories Biosimilar Products
6.2.2 Dr. Reddy’s Laboratories Biosimilars Pipeline & Future Outlook
6.2.2.1 Merck Serono Collaboration
6.2.2.2 Increasing Focus on Emerging Markets
6.3 Wockhardt – Company Overview & Analysis
6.3.1 Wockhardt Biosimilar Products
6.3.2 Wockhardt Biosimilars Pipeline & Future Outlook
6.4 Zydus Cadila – Company Overview & Analysis
6.4.1 Zydus Cadila Biosimilar Products
6.4.2 Zydus Cadila Biosimilars Pipeline & Future Outlook
6.4.2.1 Biosimilar Interferon beta-1b
6.4.2.2 Oncology Biosimilars
6.4.2.3 Inflammation Biosimilars
6.4.2.4 Thrombolytic Biosimilars
6.4.2.5 Fertility Biosimilars
6.5 Ranbaxy – Company Overview & Analysis
6.5.1 Ranbaxy Biosimilar Products
6.5.2 Ranbaxy Biosimilars Pipeline & Future Outlook
6.6 Reliance Life Sciences – Company Overview & Analysis
6.6.1 Reliance Life Sciences Biosimilar Products
6.6.2 Reliance Life Sciences Biosimilars Pipeline & Future Outlook
6.7 Intas Biopharmaceuticals – Company Overview & Analysis

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Contents
6.7.1 Intas Biopharmaceuticals Biosimilar Products
6.7.2 Intas Biopharmaceuticals Biosimilars Pipeline & Future Outlook
6.7.2.1 Biosimilar Pegylated Interferon
6.7.2.2 Biosimilar Etanercept
6.7.2.3 Biosimilar Ranibizumab
6.7.2.4 Overseas Opportunities
6.8 Other Indian Biosimilars Companies
6.8.1 Emcure Pharmaceuticals – Company Overview & Analysis
6.8.2 Shreya Life Sciences – Company Overview & Analysis
6.8.3 Cipla – Company Overview & Analysis
6.8.4 Shantha Biotechnics – Company Overview & Analysis
7. Leading Biosimilar Manufacturers in Latin America, 2016
7.1 Probiomed – Company Overview & Analysis
7.1.1 Probiomed Biosimilar Products
7.1.2 Probiomed Biosimilars Pipeline & Future Strategies
7.2 Biosidus – Company Overview & Analysis
7.2.1 Biosidus Biosimilar Products
7.2.2 Biosidus Biosimilars Pipeline & Future Strategies
7.3 Amega Biotech – Company Overview and Analysis
7.3.1 Amega – Biosimilar Products
7.3.2 Amega Biotech Biosimilars Pipeline & Future Strategies
7.4 Other Biosimilars Companies in South America
7.4.1 Bionovis – Company Overview & Analysis

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Contents
7.4.2 Orygen Biotecnologia – Company Overview & Analysis
7.4.3 Recepta – Company Overview & Analysis
8. Leading Biosimilar Manufacturers in the Rest of the World, 2016
8.1 Celltrion – Company Overview & Analysis
8.1.1 Celltrion Biosimilar Products
8.1.2 Celltrion Biosimilars Pipeline & Future Strategies
8.1.2.1 Trastuzumab Biosimilar
8.1.2.2 Rituximab Biosimilar
8.1.2.3 Four Further Development mAb Biosimilar
8.2 LG Life Sciences – Company Overview & Analysis
8.2.1 LG Life Sciences Biosimilar Products
8.2.2 LG Life Science Biosimilars Pipeline & Future Strategies
8.3 Dong-A – Company Overview & Analysis
8.3.1 Dong-A Biosimilar Products
8.3.2 Dong-A Biosimilars Pipeline & Future Strategies
8.3.2.1 DA-3803 – hCG Biosimilar
8.3.2.2 DA-3031 – Pegylated Filgrastim Biosimilar
8.3.2.3 DA-3880 – Darbepoetin Alpha Biosimilar
8.3.2.4 DA-3111 – Trastuzumab Biosimilar
8.3.2.5 DA-3113 – Adalimumab Biosimilar
8.3.2.6 3853 – Etanercept Biosimilar
8.3.2.7 DA-3808 – Recombinant Factor VIII Biosimilar
8.4 Bioton – Company Overview & Analysis

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Contents
8.4.1 Bioton’s Biosimilar Products
8.4.2 Bioton’s Biosimilars Pipeline & Future Strategies
8.5 Biocad – Company Overview & Analysis
8.5.1 Biocad’s Biosimilar Products
8.5.2 Biocad’s Biosimilars Pipeline & Future Strategies
8.6 Other Biosimilars Companies in the RoW
8.6.1 Gedeon-Richter – Company Overview & Analysis
8.6.2 Egis Pharmaceuticals - Company Overview & Analysis
8.6.3 JCR Pharmaceuticals – Company Overview & Analysis
8.6.4 Nippon Kayaku – Company Overview & Analysis
8.6.5 Fujifilm Kyowa Kirin Biologics – Company Overview & Analysis
8.6.6 Daiichi Sankyo – Company Overview & Analysis
9. Qualitative Analysis of Biosimilars Market: 2016-2026
9.1 SWOT Analysis of the Global Biosimilars Industry and Market: 2016-2026
9.1.1 Strengths
9.1.1.1 Savings in Healthcare Costs
9.1.1.2 Strong Pipeline – Innovation and Growth of the Biosimilars Market
9.1.1.3 Entry of Biosimilars Into the US market
9.1.2 Weaknesses
9.1.2.1 R&D Cost – Pricing Companies Out of Biosimilars?
9.1.2.2 Developing Market – Biosimilars Still Niche
9.1.2.3 Unclear Regulations for Biosimilars
9.1.3 Opportunities
9.1.3.1 Patent Expiry for Branded Biologics

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Contents
9.1.3.2 Increase in Prevalence of Chronic Diseases
9.1.3.3 Innovation – New Technology Driving Biosimilar Growth
9.1.3.4 Focus on Biosimilar Monoclonal Antibodies and Insulin
9.1.4 Threats
9.1.4.1 Stricter Regulations for Biosimilar Manufacturers
9.1.4.2 Lawsuits – Patent Protection from Innovator Biologics
9.1.4.3 Biobetters - Removing the Need for Biosimilars?
9.2 STEP Analysis of the Global Biosimilars Industry and Market: 2016 -2026
9.2.1 Social Factors
9.2.1.1 Global Healthcare – An Ambitious Aim?
9.2.1.2 Raising Awareness will Lead to Greater Product Adoption
9.2.2 Technological Factors
9.2.2.1 Innovation Driven – Growing Manufacturing Efficiency
9.2.2.2 High Technological Expertise Needed
9.2.3 Economic Factors
9.2.3.1 R&D for Biosimilar Development – Cost Barriers
9.2.3.2 Healthcare Savings – Cutting Spending and Costs
9.2.4 Political Factors
9.2.4.1 Government Influence – Funding for Biosimilar Industry?
9.2.4.2 International Cooperation Required
9.2.4.3 Regularly Updated Guideline Will Benefit Developers
10. Research Interviews
10.1 Mr Chandru Chawla, Head of Corporate Strategy, Cipla

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Contents
10.1.1 Cipla Overview
10.1.2 Introducing Cipla’s Biosimilars Landscape
10.1.3 Cipla’s Biosimilars Strategy: Collaboration & Competition
10.1.4 Future Directions for the Biosimilars Industry
10.2 Mr Peter Keller, Chief Business Officer, Selecta Bioscience
10.2.1 Novel Technology Platform
10.2.2 Application with Drugs
10.2.3 Biosimilar Vaccines – Future Potential?
10.2.4 Future Strategies
10.2.5 Biosimilar Market Outlook
10.3 Industry Source from a Leading Indian Biopharmaceutical Company
10.3.1 Indian Pharmaceutical and Biosimilars Market Overview
10.3.2 Indian Patent Protection – Effect on Biosimilar Industry
10.3.3 Partnerships among Biosimilar Companies
10.3.4 Future Developments in the Indian Biosimilars Market
11. Conclusions
11.1 Market Leaders Among Biosimilar Manufacturers
11.2 Will Sandoz Retain its Position as Market Leader?
11.3 Which Companies Are Best Placed to Lead in Future?
11.4 Big Pharma Companies Will Try Gain Market Entry
11.5 Contribution of Chinese and Indian Companies will Grow
11.6 Strong R&D Pipeline – Driver for Growth
11.7 Concluding Remarks

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Pharma Leader Series: 25 Top Biosimilar Drug Manufacturers,
2016-2026, and Other Rising Companies – a Market Report
Assessing Developers and Producers of Those Competitor Biologics
6.1.2 Biocon Biosimilars Market Forecast, 2016-2026
Table 6.3 Biocon: Biosimilar Products Forecast: Revenue ($bn), AGR (%), CAGR (%),
2015-2020
Biocon 2015 2016 2017 2018 2019 2020
Biosimilars Revenue
($bn)
0.255 0.296 0.349 0.410 0.481 0.560
AGR (%) 16.1 17.8 17.6 17.3 16.5
CAGR (%) 2015-2020 17.1
Table 6.4 Biocon: Biosimilar Products Forecast: Revenue ($bn), AGR (%), CAGR (%),
2021-2026
Biocon 2021 2022 2023 2024 2025 2026
Biosimilars Revenue
($bn)
0.653 0.763 0.898 1.060 1.251 1.479
AGR (%) 16.5 16.8 17.7 18.1 18.0 18.2
CAGR (%) 2020-2026
CAGR (%) 2015-2026 17.3
17.5
Between 2015 and 2026, visiongain forecasts that the biosimilars revenue for Biocon will grow with
a strong CAGR of 17.3%. This will see the biosimilars revenues rise from an estimated value of
$0.255bn in 2015 to $0.560bn by 2020 at a strong CAGR of 17.1%. This growth will continue
steadily, reaching estimated revenues of $1.479bn by 2026, and will see this growth at a rate of
17.5% from 2020 to 2026.
Source: visiongain, 2016
Source: visiongain, 2016

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Pharma Leader Series: 25 Top Biosimilar Drug Manufacturers,
2016-2026, and Other Rising Companies – a Market Report
Assessing Developers and Producers of Those Competitor Biologics
Figure 6.1 Biocon: Biosimilar Products Revenue Forecast ($bn), 2015-2026
6.1.3 Biocon Biosimilars Pipeline & Future Outlook
Biocon has a diverse portfolio of biosimilars in its pipeline. This is further helped by their
partnership deal with Mylan that allows both consolidating and strengthening their research within
this field. Biocon’s commitment to their biosimilars business is reinforced by their announcement
that they have built a new biopharmaceutical R&D manufacturing facility in Malaysia which was
opened in 2015. The company has spent a reported $161 million on the facility and is reportedly a
wholly owned subsidiary of the company.
Moreover, the company has one of the largest and most extensive R&D pipelines within the
biosimilars field, as Table 6.5 show s.
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
1.60
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Revenue($bn)
Year
Source: visiongain, 2016