Biosimilars and follow-on Biologics: World Industry and Market Prospects 2015-2025

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Biosimilars and Follow-On Biologics:
World Industry and Market Prospects
2015-2025

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Biosimilars and Follow-On Biologics: World
Industry and Market Prospects 2015-2025
1.1 Biosimilars Overview
1.2 Biosimilars Market Segmentation
1.3 Why You Should Read this Report
1.4 How this Report Delivers
1.5 Main Questions Answered by this Report
1.6 Who is this Report for?
1.7 Research and Analysis Methods
1.8 Frequently Asked Questions (FAQ)
1.9 Some Associated Reports
1.10 About Visiongain
2.1 Biologics: Large, Complex Products which can be Very Effective, but also Very Expensive
2.2 Brief History of Biological Drug Development
2.3 What is a Biosimilar?
2.4 Brief History of Biosimilars
2.5 What are Interchangeable Biological Products and how Do They Differ from Biosimilars?
2.6 Prescription of Interchangeables vs Biosimilars and How This Sets the FDA Apart from the EMA
2.7 Main Segments of the Overall Biosimilars Market
3.1 The Global Biosimilars Market
3.2 Global Biosimilars Market Forecast 2015-2025
3.3 What Will Drive Growth in the Biosimilars Market?
3.3.1 Biosimilars Can Bring about Savings of Billions - $44bn for the US by 2024 and $33bn for Europe
by 2020
1. Report Overview
2. Introduction to Biosimilars and Biosimilar Drug Development
3. The Global Biosimilars Market 2015-2025

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3.3.2 Over $67bn worth of Biologic Patents due to Expire by 2020
3.3.3 US Approves First Biosimilar - Zarxio. Will this Open the Floodgates? Interchangeability Can also
Drive Growth
3.3.4 Other Developed and Emerging Markets Will also Provide Opportunities for Growth
3.3.5 Competitive Landscape Emerging for Biosimilars
3.4 What Factors can Restrain Sales Growth in the Biosimilars Market?
3.4.1 Complexity of Biologics Means that Biosimilar Development Faces Many Challenges
3.4.2 Opposition from Originator Companies and Patent Issues
3.4.3 Fragmentation in the Market as Many Companies Chase the Same Targets
3.4.4 The Threat of Biobetters and Next-Generation Biologics
3.5 Summary of Drivers and Restraints for the Global Biosimilars Market
3.6 Biosimilar Market Forecast by Segment, 2015-2025
3.7 Leading Segments in the Biosimilars Market, 2014
3.8 Biosimilars as a Share of the Biologics Market, 2014
3.8.1 Outlook for the Overall Biologics Market
3.8.2 Seven Biologics Account for 31.8% of Total Market Revenue
4.1 Regional Forecasts for the Global Biosimilars Market, 2015-2025
4.2 The US Biosimilars Market Outlook, 2015-2025
4.2.1 Current Status of the US Market
4.2.2 FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
4.2.2.1 The History of the US’ Biosimilar Guidelines
4.2.3 Individual States Can Pass their Own Biosimilar Substitution Laws
4.2.4 US Biosimilars Market Forecast, 2015-2025
4.3 The European Biosimilar Market: History and Current Status
4.3.1 History of EMA Guidelines and Updates 2012-2014
4.3.2 Biosimilar Uptake in Europe Varies between Nations
4.3.3 European Biosimilars Market Forecast, 2015-2025
4. Outlook for Biosimilars in Leading Developed Markets, 2015-2025

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4.3.4 Inflectra and Remsima in Europe - Demonstrates a Path for Other Biosimilar MAbs
4.3.5 German Biosimilar Market Outlook, 2015
4.3.5.1 German Biosimilar Market Forecast, 2015-2025
4.3.6 French Biosimilars Market Outlook, 2015
4.3.6.1 Biosimilar Substitution Law Likely to Come into Effect in 2015
4.3.6.2 French Biosimilar Market Forecast, 2015-2025
4.3.7 UK Biosimilar Market Outlook, 2015
4.3.7.1 UK Biosimilar Market Forecast, 2015-2025
4.3.8 Italian Biosimilars Market Outlook, 2015
4.3.8.1 Italian Biosimilars Market Forecast, 2015-2025
4.3.9 Spanish Biosimilars Market Outlook, 2015
4.3.9.1 Spanish Biosimilar Market Forecast, 2015-2025
4.3.10 Biosimilar Regulation in Japan and Currently Approved Biosimilars
4.3.10.1 Differences between the European and Japanese Guidelines
4.3.10.2 Currently Approved Biosimilars in Japan
4.3.10.3 Japanese Biosimilar Market Forecast, 2015-2025
5.1 China and India Lead Biosimilar Revenues
5.2 Biosimilar Growth in Emerging National Markets, 2015-2025
5.3 Chinese Biosimilars Market Outlook, 2015
5.3.1 China Publishes Final Guidelines for Biosimilars
5.3.2 Biosimilars Account for less than Half of Biotech Revenues in China
5.3.3 Chinese Biosimilars Market Forecast, 2015-2025
5.4 Indian Biosimilars Market Outlook, 2015
5.4.1 CDSCO Guidelines Released in 2012
5.4.2 Indian Biosimilars Market Forecast, 2015-2025
5.5 South Korea’s Established Biosimilar Guidelines
5.5.1 Currently Approved Biosimilars in South Korea, 2015
5. Outlook for Biosimilars in Emerging Markets, 2015-2025

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5.5.2 South Korean Biosimilars Market Forecast, 2015-2025
5.6 Russian Biosimilars Market Outlook and Forecast, 2015-2025
5.7 Brazilian Biosimilar Regulation
5.7.1 Government Eager to Promote Biosimilar Development, and Two Major Conglomerates, Bionovis
and Orygen, are Racing to Produce Biosimilars
5.7.2 Brazilian Biosimilars Market Forecast, 2015-2025
6.1 Monoclonal Antibodies (mAbs): The Largest Biologics Market Sector, Individual Drugs
Accumulating Multi-Billion Dollar Revenues
6.2 Biosimilar MAbs and FPs Market Forecast, 2015-2025
6.3 Drivers for the Biosimilar MAbs and FPs Market
6.3.1 New Launches of Biosimilar MAbs and FPs in Developed and Emerging Markets
6.3.2 Rising Incidence of Cancer will Drive Demand
6.3.3 The Need for Lower Cost Therapies
6.3.4 Partnering to Launch Biosimilar MAbs
6.4 Restraints for the Biosimilar MAbs and FPs Market
6.4.1 Novel MAb Developers Choosing to Develop Biobetters and Next-Generation Therapies in Face
of Biosimilar Competition
6.4.1.1 Hope for Biosimilars when Competing Against Next-Generation Therapies
6.4.2 Challenges in Antibody Development and Manufacturing
6.4.3 Patent Issues, Market Fragmentation and Perception of Biosimilars
6.5 Leading Targets for Biosimilar Development, 2015-2025
6.6 Biosimilar Rituximab
6.6.1 Approved Biosimilars
6.6.1.1 Reditux (Dr. Reddy’s Laboratories)
6.6.1.2 MabTas (Intas Pharmaceutical)
6.6.1.3 AcellBia (Biocad)
6. Biosimilar Monoclonal Antibodies and Fusion Proteins: Submarket
Forecast and Pipeline, 2015-2025

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6.6.1.4 Kikuzubam (PROBIOMED) - Challenges
6.6.2 Biosimilar Rituximab Pipeline, 2015-2025
6.6.2.1 Terminated Developments
6.6.2.2 GP2013 (Sandoz)
6.6.2.3 BI 695500 (Boehringer Ingelheim)
6.6.2.4 MabionCD20 (Mabion)
6.6.2.5 CT-P10 (Celltrion)
6.6.2.6 PF-05280586 (Pfizer)
6.6.3 Biosimilar Rituximab Outlook, 2015-2025
6.7 Biosimilar Infliximab
6.7.1.1 Inflectra and Remsima (Hospira and Celltrion)
6.7.1.2 Inflimab and BOW015 (Epirus Biopharmaceuticals and Ranbaxy Laboratories)
6.7.2 Biosimilar Infliximab Pipeline, 2015-2025
6.7.2.1 NI-071 (Nichi-Iko)
6.7.2.2 ABP 710 (Amgen) and BX2922 (BioXpress Therapeutics)
6.7.3 Biosimilar Infliximab Outlook, 2015-2025
6.8 Biosimilar Trastuzumab
6.8.1.1 Hertraz and CanMab (Mylan and Biocon)
6.8.1.2 Herzuma (Celltrion)
6.8.2 Biosimilar Trastuzumab Pipeline, 2015-2025
6.8.2.1 BCD-022 (Biocad)
6.8.2.2 ABP 980 (Amgen and Actavis)
6.8.2.3 PF-05280014 (Pfizer)
6.8.3 Biosimilar Trastuzumab Outlook, 2015-2025
6.9 Biosimilar Adalimumab
6.9.1 Humira - The World’s Leading Antibody Therapy
6.9.2 Exemptia (Zydus Cadila)
6.9.3 Biosimilar Adalimumab R&D Pipeline, 2015-2025

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6.9.3.1 ABP 501 (Amgen and Actavis)
6.9.3.2 GP2017 (Sandoz)
6.9.3.3 BI 695501 (Boehringer Ingelheim)
6.9.4 Biosimilar Adalimumab Outlook, 2015-2025
6.10 Biosimilar Etanercept
6.10.1 Enbrel is the Leading Fusion Protein
6.10.2 Enbrel Granted Extended Patent Protection in the US until 2029
6.10.3 Biosimilars are Available in Emerging Markets
6.10.3.1 Yisaipu (Shanghai CP Guojian Pharmaceutical) and Qiangke (Shanghai Celgen
Biopharmaceutical)
6.10.3.2 Etacept (Cipla) and Intacept (Intas Pharmaceuticals)
6.10.3.3 Davictrel and HD-203 (Hanwha Chemical)
6.10.4 Biosimilar Etanercept Pipeline, 2015-2025
6.10.4.1 GP2015 (Sandoz)
6.10.4.2 CHS-0214 (Coherus Biosciences and Baxter)
6.10.5 Biosimilar Etanercept Outlook, 2015-2025
6.11 Avastin: Patents Not Set to Expire until 2019 in the US and 2022 in Europe
6.11.1 Biosimilar Bevacizumab Pipeline, 2015-2025
6.11.1.1 BCD-021 (Biocad)
6.11.1.2 ABP 215 (Amgen)
7.1 Insulin as Part of the Biological Drug Sector, 2015
7.2 30 Million People Expected to be Diagnosed with Diabetes by 2030
7.3 Approved Insulin Biosimilars
7.4 Abasaglar and Insulin Glargine BS - The First Insulin Biosimilars to be Approved in Developed
Markets
7.5 EMA Releases Finalised Insulin Biosimilars Guideline
7.6 Tentative Approval for Basaglar in the US, but Launch Delayed until Mid-2016
7. Biosimilar Insulin Submarket Outlook, 2015-2025

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7.7 Biosimilar Insulin Forecast, 2015-2025
7.8 Drivers for the Biosimilar Insulin Market, 2015-2025
7.9 Restraints for the Biosimilar Insulin Market, 2015-2025
7.10 Biosimilar Human Insulin Submarket, 2015-2025
7.10.1 A Submarket Mostly Restricted to Emerging Markets?
7.10.2 Biosimilar Human Insulin in China
7.10.3 Biosimilar Human Insulin in India
7.10.3.1 Wockhardt and Biocon - Given up on their Desire to Target the US and Europe?
7.10.4 Biosimilar Human Insulin Outlook, 2015-2025
7.11 Biosimilar Insulin Analogues
7.11.1 Available Biologic Insulin Analogues - Sanofi’s Lantus Tops Revenues
7.11.2 Insulin Glargine is the Main Biosimilar Target
7.11.2.1 Limited Development for the Other Targets
7.11.3 Insulin Market Leaders are Developing Ultra-Rapid Acting Insulin Analogues
7.11.3.1 Ultra-Long Acting Insulin also in Development
7.11.4 Mylan Partners with Biocon for Insulin Analogues
7.11.5 Biosimilar Insulin Analogue Outlook, 2015-2025
7.12 Biosimilar Insulin Glargine
7.12.1 Two Biosimilars are Available in India
7.12.2 Biosimilar Insulin Glargine Pipeline, 2015-2025
7.12.2.1 MK-1293 (Merck & Co. and Samsung BioLogics)
7.12.2.2 Mylan’s Insulin Glargine (Mylan)
7.12.3 Biosimilar Insulin Glargine Outlook, 2015-2025
7.13 Biosimilar Insulin Lispro
7.13.1 One Biosimilar Currently Available - Prandilin
7.13.2 Small Pipeline for the Future
7.13.3 Ultra-Rapid Acting Insulin: New Options

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8.1 Three Products Lead the Biologic EPO Therapy Market
8.2 Safety Concerns for Erythropoietin-Stimulating Agents
8.3 The Challenge from Oral Therapies is Coming
8.4 Treating Anaemia in Patients with CKD - the Leading Use of EPO Therapies
8.5 Biosimilar Epoetin Approvals in Europe
8.6 Epoetin Alfa Pipeline for the European Market, 2015
8.7 Trends in Uptake for Biosimilar Epoetins in Europe
8.8 Epoetin Alfa Pipeline for the US - Companies Preparing for Launch
8.9 Biosimilar Epoetin in Japan
8.10 Biosimilar Epoetin in South Korea
8.11 Biosimilar Epoetin in India and China
8.12 Second-Generation EPO Biosimilars
8.13 No Mircera Biosimilars in Clinical Development
8.14 Biosimilar EPO Market Forecast, 2015-2025
9.1 Biologic Market Outlook: Amgen Leads the Biologic G-CSF Market
9.2 Teva Launches Long-Acting Pegfilgrastim
9.3 Selected Filgrastim Biosimilars Approved Worldwide
9.3.1 The European G-CSF Biosimilars Market
9.3.2 Tevagrastim (Teva): The First Biosimilar in Europe, Launched as Granix in the US
9.3.3 Nivestim (Hospira)
9.3.4 Zarzio (Sandoz): The Most Prescribed Biosimilar Therapy in Europe
9.3.4.1 Zarxio Becomes the First Biosimilar in the US
9.3.5 Multiple Launches in Japan 2013-2014
9.3.6 Biosimilar Filgrastim and Pegfilgrastim in India
9.3.6.1 Biosimilars in Russia and Other Emerging Markets
8. Biosimilar Erythropoietins Submarket Outlook, 2015-2025
9. Biosimilar G-CSF Submarket Outlook, 2015-2025

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9.4 Biosimilar G-CSF Market Forecast, 2015-2025
9.4.1 Drivers and Restraints for the Biosimilar G-CSF Market
9.4.2 Trends in Biosimilar Uptake Across Europe
10.1 Competition for the Multiple Sclerosis Market - Challenges for Interferon Beta Therapies
10.2 All-Oral Regimens will Challenge Interferon Alfa Therapy
10.2.1 However Oral Therapies Will be Expensive
10.3 Biologic Interferon Therapy Market Outlook
10.4 There Are No Approved Biosimilars in Developed Markets
10.5 Biosimilar Interferons Market Forecast, 2015-2025
10.6 Biosimilar Interferon Alfa
10.6.1 Biosimilar Interferon Alfa - a Common Target in Developing Countries, Leading to Fragmented
Markets
10.6.2 Biosimilar Peginterferon Alfa
10.6.3 Hepatitis Treatment Rates are Low
10.6.4 Biosimilar Interferon Alfa Outlook, 2015-2025
10.7 Biosimilar Interferon Beta
10.7.1 Biosimilars are Well-Established in Emerging Markets
10.7.2 Biosimilar Interferon Beta Pipeline
10.7.3 EMA Guidance
10.7.4 Long-Acting Interferon Beta
10.7.5 Biosimilar Interferon Beta Outlook, 2015-2025
11.1 Biologic Growth Hormone Market in 2014 - Novo Nordisk and Pfizer Dominate
11.1.1 Biologic Growth Hormone Market Outlook, 2015-2025
11.2 Biosimilar Growth Hormones
11.2.1 Omnitrope - Well Established in Developed Markets
10. Biosimilar Interferons Submarket Outlook, 2015-2025
11. Biosimilar Recombinant Hormones Submarket Outlook, 2015-2025

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11.2.2 Multiple Biosimilars Available Worldwide
11.2.3 Biosimilar Growth Hormones in Asia
11.2.4 Biosimilar Uptake Varies by Region
11.2.5 Biosimilar Growth Hormones Market Forecast, 2015-2025
11.3 Fertility Hormones
11.3.1 Two Products Lead the Biologic Fertility Hormone Market
11.3.2 Long-Acting Follicle Stimulating Hormone (FSH)
11.3.3 Biologic Fertility Hormones Market Outlook
11.3.4 Available Biosimilar Fertility Hormones
11.3.4.1 Ovaleap (Teva) and Bemfola (Finox) Approved in Europe
11.3.5 Rising Infertility to Drive Demand to 2025
11.3.6 Biosimilar Fertility Hormones Forecast, 2015-2025
12.1 SWOT Analysis of the Biosimilars Market
12.2 Biosimilars Market: Strengths
12.2.1 Biosimilars Can Offer Huge Cost Savings
12.2.2 The US Finally Joins the Global Biosimilars Market
12.2.3 Biosimilars are Already Well-Established in Many National Markets
12.2.4 Outsourcing Offers the Chance for Further Cost Savings
12.3 Biosimilars Market: Weaknesses
12.3.1 Biosimilars are High Cost to Develop and Manufacture
12.3.2 Complexity Means that Development Timelines are Long
12.3.3 Uptake for Biosimilars Varies and is Low in Some Regions
12.4 Biosimilars Market: Opportunities
12.4.1 Blockbuster Biologics Face Patent Expiry
12.4.2 Rising Disease Prevalence
12.4.3 Licensing Agreements for Biosimilars
12.5 Threats
12. Biosimilars: Qualitative Analysis and Industry Trends, 2015

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12.5.1 Biobetters and Next-Generation Biologics
12.5.2 Patent Issues and Product Life Cycle Management from Originator Companies
12.5.3 Fragmentation in the Market
12.5.4 Long Market and Data Exclusivity Periods
12.5.5 Biosimilars Require Marketing and Education
13.1 Interview with PROBIOMED
13.1.1 Introduction to PROBIOMED
13.1.2 PROBIOMED’s Most Prominent Biosimilars and its Future Pipeline
13.1.3 Withdrawal of Kikuzubam and Changes in Mexican Biosimilar Regulation
13.1.4 On Standing out from the Competition
13.1.5 On How the Biosimilars Market will Develop over the Next Ten Years and its Main Strengths
13.2 Interview with Dr Ralph Warsinsky, Executive Director of Product Communications at Boehringer
Ingelheim
13.2.1 On Boehringer Ingelheim’s Current Biosimilar Pipeline and its Reasons for Entering the
Biosimilars Space
13.2.2 On Boehringer Ingelheim’s Track Record with Biopharmaceuticals and the Factors Needed to
Become Successful in the Biosimilars Industry
13.2.3 Advantages over Competitors and Thoughts on the US Market
14.1 Rapid Growth Expected for this High-Potential Market
14.2 Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
14.3 A Range of Factors Will Stimulate Demand
14.4 Challenges Remain in Developing and Successfully Launching Biosimilars
13. Research Interviews from Our Survey
14. Conclusions from Visiongain’s Research and Analysis

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present a ‘tried and tested’ template to other biosimilar mAb developers - demonstrating a pathway
to the market and indicating the levels of pre-clinical and clinical data they will require in order to
receive approval from the EMA.
4.3.5 German Biosimilar Market Outlook, 2015
The largest national market for biosimilar revenues in Europe is Germany, accounting for 33.1% of
sales in that region in 2014. Germany has among the highest uptake rates for both biosimilar
filgrastim and biosimilar epoetin alfa in Europe - more than half of prescriptions of each are filled
with biosimilars, we note. This follows the trend from the small molecule drug market, where
Germany has the highest rate of generic drug use in the region.
In Europe, Germany is the country that provides the strongest incentives for prescribing biosimilars
- it has a prescription quota system and sickness funds for biosimilars. The prescription quotas
vary by city, one source reports that EPO quotas are 40% in Berlin but 20% in Hamburg. Analysis
of prescribing data shows that, where quotas exist, rates of uptake tend to outstrip the levels of
these quotas.
While rates of biosimilar use in Germany are high, uptake has been restrained by tendering
processes and the fact that Germany has reference prices, reports suggest. The German generic
drugs association, Pro Generika, reports that in some cases, biosimilars are forced to compete at a
price similar to that of the reference biologic, which cuts the main advantage they hold over the
branded therapy.
4.3.5.1 German Biosimilar Market Forecast, 2015-2025
Table 4.8, 4.9 and Figure 4.5 show visiongain’s forecast for the German biosimilars market from
2014-2025.
Table 4.8 German Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%),
Market Share (%), 2014-2019
Column1 2014 2015 2016 2017 2018 2019
Germany
Revenues ($bn) 0.14 0.21 0.33 0.50 0.76 1.08
Annual Growth Rate (%) 56 52 54 51 42
CAGR (%, 2014-2019) 51
European Market Share (%) 33.1 33.5 32.8 32.0 31.5 30.7
Source: visiongain 2015. Note regarding rounding: Revenues have been rounded to 2 decimals, Market Shares have
been rounded to 1 decimal, and AGRs and CAGRs have been rounded to whole numbers.

Figure 4.5 German Biosimilars Market: Revenue ($bn), 2014-2025
Table 4.9 German Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%),
Column1 2020 2021 2022 2023 2024 2025
Germany
Revenues ($bn) 1.45 1.70 1.96 2.20 2.45 2.70
Annual Growth Rate (%) 35 17 15 12 12 10
CAGR (%, 2019-2025) 17
CAGR (%, 2014-2025) 31
been rounded to 1 decimal, and AGRs and CAGRs have been rounded to whole numbers. Due to rounding, values may
not add up exactly.
0
0.5
1
1.5
2
2.5
3
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Revenue($bn)
Year
Source: visiongain 2015.

Figure 4.9 Spanish Biosimilars Market: Revenue ($bn), 2014-2025
Demand for healthcare cost savings will raise uptake of biosimilars in Spain in the coming ten
years, we believe, driving strong growth in the market. The Spanish biosimilars market was worth
only $0.02bn in 2014, but will exhibit strong growth with a CAGR of 57% to 2019, reaching
revenues of $0.22 in 2019, and $0.64bn in 2025. The CAGR for 2019-2025 will be 20%, and the
Table 4.17 Spanish Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%),
been rounded to 1 decimal, and AGRs and CAGRs have been rounded to whole numbers. Due to rounding, values may
not add up exactly.
Column1 2020 2021 2022 2023 2024 2025
Spain
Revenues ($bn) 0.30 0.37 0.43 0.50 0.57 0.64
Annual Growth Rate (%) 41 21 18 16 14 12
CAGR (%, 2019-2025) 20
CAGR (%, 2014-2025) 35
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Revenue($bn)
Year
Source: visiongain 2015.

Biosimilars and follow-on Biologics: World Industry and Market Prospects 2015-2025

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Biosimilars and follow-on Biologics: World Industry and Market Prospects 2015-2025