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Biosimilars Market by Product, Manufacturing, Application - Global Forecast to 2021

  • ID: 4031665
  • Report
  • January 2017
  • Region: Global
  • 154 Pages
  • Markets and Markets
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The Global Biosimilars Market is Expected to Reach USD 10.90 Billion by 2021 from USD 3.39 Billion in 2016, at a CAGR of 26.3%

FEATURED COMPANIES

  • Amgen Inc.
  • Biocon Ltd.
  • Celltrion Inc.
  • Dr. Reddy's Laboratories
  • F. Hoffmann-La Roche Ltd.
  • Mylan Inc.
  • MORE

Biosimilars Market by Product (Recombinant Non-glycosylated Proteins (Insulin, rHGH, Interferon), glycosylated (mAb, EPO), Peptides (Glucagon, Calcitonin)), Manufacturing (In-House, CMO), Application (Oncology, Blood Disorders) - Global Forecast to 2021

The market is broadly classified into product, manufacturing type, application, and region.

On the basis of product, biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant glycosylated proteins segment is projected to witness the highest CAGR during the forecast period due to broad therapeutic area of these proteins; presence of biosimilar versions of monoclonal antibodies at lower prices compared to reference products; numerous biologic drugs under class monoclonal antibody, follitropin, and erythropoietin going off-patent; and numerous products in pipeline.

On the basis of manufacturing type, the biosimilars market is segmented into in-house manufacturing and contract manufacturing organizations. The contract manufacturing organizations segment is projected to grow at the highest CAGR during the forecast period due to cost-saving benefits to companies in terms of facilities, equipment, and labor costs.

On the basis of application, the biosimilars market is segmented into oncology, blood disorders, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases, and other applications. The oncology segment is projected to witness the highest CAGR during the forecast period.

Geographically, the biosimilars market is dominated by Europe, followed by Asia, North America, and the Rest of the World (RoW). However, growth in Europe primarily driven by the growing pressure to curtail healthcare costs, patent expiry of biologic products and the arrival of new biosimilars, rising incidence of chronic disorders (such as cancer, diabetes, and rheumatoid arthritis), and the emergence of new market participants. However, the Asian market is projected to grow at the highest CAGR during the forecast period.

Key players in the biosimilars market include by Pfizer Inc. (U.S.), Sandoz International GmbH (Germany), Teva Pharmaceuticals Industries Ltd. (Israel), Amgen Inc. (U.S.), Biocon Ltd. (India), Dr. Reddy’s Laboratories Ltd. (India), F. Hoffmann-La Roche Ltd. (Switzerland), Celltrion, Inc. (South Korea), and Samsung Bioepis (South Korea).

Target Audience for this Report:

  • Biopharmaceutical drug manufacturers (biosimilars and biologics)
  • Private equity companies and venture capital firms
  • Healthcare service providers (hospitals and independent physicians)
  • Health insurance payers
  • Research and consulting service firms
  • Contract research organizations (CROs)
  • Contract manufacturing organizations (CMOs)
  • Biotechnology, biopharmaceutical, and pharmaceutical companies
  • Pharmaceutical and medical associations

Value Addition for the Buyer:

This report aims to provide insights into the global biosimilars market. The market is segmented on the basis of product, manufacturing type, and application. Furthermore, the information for these segments, by region, is also presented in this report. Leading players in the market are profiled to study their product offerings and understand the strategies undertaken by them to be competitive in this market.

The above-mentioned information would benefit buyers by helping them understand the market dynamics. In addition, the forecasts provided in the report will enable firms to understand the trends in this market and better position themselves to capitalize the growth opportunities.

This report categorizes the biosimilars market into the following segments:

Biosimilars Market, by Product

  • Recombinant Non-glycosylated Proteins
  • Insulin
  • Recombinant Human Growth Hormones
  • Granulocyte Colony-stimulating Factor
  • Interferons
  • Recombinant Glycosylated Proteins
  • Erythropoietin
  • Monoclonal Antibodies
  • Follitropin
  • Recombinant Peptides
  • Glucagon
  • Calcitonin

Biosimilars Market, by Manufacturing Type

  • In-house Manufacturing
  • Contract Manufacturing Organizations

Biosimilars Market, by Application

  • Oncology
  • Blood Disorders
  • Chronic & Autoimmune Diseases
  • Growth Hormone Deficiency
  • Infectious Diseases
  • Other Applications

Biosimilars Market, by Region

  • North America
  • Europe
  • Asia
  • Rest of the World (Australia, New Zealand, Latin America, the Middle East, and Africa)
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Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Amgen Inc.
  • Biocon Ltd.
  • Celltrion Inc.
  • Dr. Reddy's Laboratories
  • F. Hoffmann-La Roche Ltd.
  • Mylan Inc.
  • MORE

1 Introduction
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Market Covered
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology
2.1 Secondary Data
2.1.1 Key Data from Secondary Sources
2.2 Primary Data
2.2.1 Key Data from Primary Sources
2.3 Market Size Estimation
2.3.1 Bottom-Up Approach
2.3.2 Top-Down Approach
2.4 Market Breakdown & Data Triangulation
2.5 Assumptions for the Study

3 Executive Summary
3.1 Introduction
3.2 Conclusion

4 Premium Insights
4.1 Biosimilars: Market Overview
4.2 Geographic Analysis: Biosimilars Market, by Product
4.3 Biosimilars Market Size, by Application, 2016 Vs. 2021

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Rising Incidences of Diseases
5.2.1.2 Increasing Demand for Biosimilar Drugs Due to Their Cost-Effectiveness
5.2.1.3 Growing Pressure to Curtail Healthcare Expenditure
5.2.1.4 Rising Geriatric Population
5.2.1.5 Strategic Collaborations Resulting in Enhanced Productivity and Clinical Trial Activities for Biosimilars
5.2.1.6 Increasing Government Support and Initiatives to Develop and Promote Biosimilars
5.2.2 Restraints
5.2.2.1 Complexities in Manufacturing and High Costs
5.2.2.2 Innovative Strategies by Biologic Drug Manufacturers
5.2.3 Opportunities
5.2.3.1 Emerging Markets
5.2.3.2 New Indications and Patent Expiry of Biologic Products
5.2.4 Challenge
5.2.4.1 Stringent Regulatory Requirements to Adversely Affect Investments in Biosimilars
5.3 Key Pipeline Products
5.4 Regulatory Outlook
5.4.1 North America
5.4.1.1 U.S.
5.4.1.2 Canada
5.4.2 Europe
5.4.3 Asia
5.4.3.1 China
5.4.3.2 India
5.4.3.3 Japan
5.4.3.4 South Korea
5.4.4 Rest of the World
5.4.4.1 Brazil
5.4.4.2 Mexico
5.4.4.3 Argentina
5.4.4.4 Saudi Arabia
5.5 Biosimilars Services Industry Insights
5.5.1 Introduction
5.5.2 Contract Manufacturing Organizations
5.5.3 Contract Research Organizations
5.5.4 Other Services (Nonclinical & Bioinformatics)

6 Biosimilars Market, by Type of Product
6.1 Introduction
6.2 Recombinant Non-Glycosylated Proteins
6.2.1 Insulin
6.2.2 Recombinant Human Growth Hormone (RHGH)
6.2.3 Granulocyte Colony-Stimulating Factor (Filgrastim)
6.2.4 Interferons
6.3 Recombinant Glycosylated Proteins
6.3.1 Erythropoietin (EPO)
6.3.2 Monoclonal Antibodies (MABS)
6.3.3 Follitropin
6.4 Recombinant Peptides
6.4.1 Glucagon
6.4.2 Calcitonin

7 Biosimilars Market, by Type of Manufacturing
7.1 Introduction
7.2 In-House Manufacturing
7.3 Contract Manufacturing Organizations

8 Biosimilars Market, by Application
8.1 Introduction
8.2 Oncology
8.3 Chronic and Autoimmune Diseases
8.4 Blood Disorders
8.5 Growth Hormone Deficiency
8.6 Infectious Diseases
8.7 Other Applications

9 Biosimilars Market, by Region
9.1 Introduction
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 Germany
9.3.2 France
9.3.3 U.K.
9.3.4 Italy
9.3.5 Spain
9.3.6 Rest of Europe
9.4 Asia
9.4.1 China
9.4.2 India
9.4.3 Japan
9.4.4 South Korea
9.4.5 Rest of Asia (Roa)
9.5 Rest of the World (Row)

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Situation and Trends
10.3.1 Regulatory Approvals
10.3.2 Agreements, Collaborations, and Partnerships
10.3.3 Product Launches
10.3.4 Acquisitions
10.3.5 Expansions
10.3.6 Other Developments

11 Company Profiles
11.1 Introduction
11.2 Pfizer Inc.
11.3 Sandoz International Gmbh (A Division of Novartis International Ag)
11.4 Teva Pharmaceutical Industries Ltd.
11.5 F. Hoffmann-La Roche Ltd.
11.6 Amgen Inc.
11.7 Biocon Ltd.
11.8 Dr. Reddy's Laboratories
11.9 Celltrion Inc.
11.10 Mylan Inc.
11.11 Samsung Bioepis

List of Tables
Table 1 Biosimilars Market Summary
Table 2 Biosimilars Market: Major Collaborations (2012-2015)
Table 3 List of Key Biologics Under the Threat of Patent Expiry
Table 4 Biosimilars in Clinical Trials
Table 5 Status of Regulatory Pathway in North America
Table 6 Substitution Status in European Countries
Table 7 Status of Regulatory Pathway in Asia
Table 8 Status of Regulatory Pathway in the Row
Table 9 Joint Ventures Between Cmos & Pharmaceutical Companies for Biosimilars
Table 10 Biosimilars Market Size, by Product Type, 2014-2021 (USD Million)
Table 11 Biosimilar Recombinant Non-Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 12 Biosimilar Recombinant Non-Glycosylated Proteins Market Size,  by Region, 2014-2021 (USD Million)
Table 13 North America: Biosimilar Recombinant Non-Glycosylated Proteins Market Size, by Country, 2014-2021 (USD Million)
Table 14 Europe: Biosimilar Recombinant Non-Glycosylated Proteins Market Size, by Country, 2014-2021 (USD Million)
Table 15 Asia: Biosimilar Recombinant Non-Glycosylated Proteins Market Size, by Country, 2014-2021 (USD Million)
Table 16 Biosimilar Insulin Market Size, by Region, 2014 -2021 (USD Million)
Table 17 Biosimilar Recombinant Human Growth Hormone Market Size,  by Region, 2014-2021 (USD Million)
Table 18 List of Approved Biosimilars for Granulocyte Colony-Stimulating Factor Products from 2013 to 2016
Table 19 Biosimilar Granulocyte Colony-Stimulating Factor Market Size,  by Region, 2014-2021 (USD Million)
Table 20 Biosimilar Interferons Market Size, by Region, 2014-2021 (USD Million)
Table 21 Biosimilar Recombinant Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 22 Biosimilar Recombinant Glycosylated Proteins Market Size,  by Region, 2014-2021 (USD Million)
Table 23 North America: Biosimilar Recombinant Glycosylated Proteins Market Size, by Country, 2014-2021 (USD Million)
Table 24 Europe: Biosimilar Recombinant Glycosylated Proteins Market Size,  by Country, 2014-2021 (USD Million)
Table 25 Asia: Biosimilar Recombinant Glycosylated Proteins Market Size,  by Country, 2014-2021 (USD Million)
Table 26 Biosimilar Erythropoietin Market Size, by Region,  2014-2021 (USD Million)
Table 27 Biosimilar Monoclonal Antibodies Market Size, by Region,  2014-2021 (USD Million)
Table 28 Biosimilar Follitropin Market Size, by Region, 2014-2021 (USD Million)
Table 29 Biosimilar Recombinant Peptides Market Size, by Type,  2014-2021 (USD Million)
Table 30 Biosimilar Recombinant Peptides Market Size, by Region,  2014-2021 (USD Million)
Table 31 North America: Biosimilar Recombinant Peptides Market Size,  by Country, 2014-2021 (USD Million)
Table 32 Europe: Biosimilar Recombinant Peptides Market Size, by Country, 2014-2021 (USD Million)
Table 33 Asia: Biosimilar Recombinant Peptides Market Size, by Country,  2014-2021 (USD Million)
Table 34 Biosimilar Glucagon Market Size, by Region, 2014-2021 (USD Million)
Table 35 Biosimilar Calcitonin Market Size, by Region, 2014-2021 (USD Million)
Table 36 Biosimilars Market Size, by Manufacturing Type,  2014-2021 (USD Million)
Table 37 Biosimilars Market Size for In-House Manufactuirng,  by Region, 2014-2021 (USD Million)
Table 38 Biosimilars Market Size for Contract Manufacturing Organizations,  by Region, 2014-2021 (USD Million)
Table 39 Biosimilars Market Size, by Application, 2014-2021 (USD Million)
Table 40 Biosimilars Market Size for Oncology, by Region,  2014-2021 (USD Million)
Table 41 Biosimilars Market Size for Chronic and Autoimmune Diseases,  by Region, 2014-2021 (USD Million)
Table 42 Biosimilars Market Size for Blood Disorders, by Region,  2014-2021 (USD Million)
Table 43 Biosimilars Market Size for Growth Hormone Deficiency,  by Region, 2014-2021 (USD Million)
Table 44 Biosimilars Market Size for Infectious Diseases, by Region,  2014-2021 (USD Million)
Table 45 Biosimilars Market Size for Other Applications, by Region,  2014-2021 (USD Million)
Table 46 Biosimilars Market Size, by Region, 2014-2021 (USD Million)
Table 47 North America: Biosimilars Market Size, by Country,  2014-2021 (USD Million)
Table 48 North America: Biosimilars Market Size, by Product,  2014-2021 (USD Million)
Table 49 North America: Recombinant Non-Glycosylated Proteins Market Size, by Type, 2014-2021 (USD Million)
Table 50 North America: Recombinant Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 51 North America: Recombinant Peptides Market Size, by Type,  2014-2021 (USD Million)
Table 52 North America: Biosimilars Market Size, by Application,  2014-2021 (USD Million)
Table 53 North America: Biosimilars Market Size, by Manufacturing Type,  2014-2021 (USD Million)
Table 54 U.S.: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 55 Canada: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 56 Europe: Biosimilars Market Size, by Country, 2014-2021 (USD Million)
Table 57 Europe: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 58 Europe: Recombinant Non-Glycosylated Proteins Market Size, by Type, 2014-2021 (USD Million)
Table 59 Europe: Recombinant Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 60 Europe: Recombinant Peptides Market Size, by Type,  2014-2021 (USD Million)
Table 61 Europe: Biosimilars Market Size, by Application,  2014-2021 (USD Million)
Table 62 Europe: Biosimilars Market Size, by Manufacturing Type,  2014-2021 (USD Million)
Table 63 Germany: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 64 France: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 65 U.K.: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 66 Italy: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 67 Spain: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 68 Roe: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 69 Asia: Biosimilars Market Size, by Country, 2014-2021 (USD Million)
Table 70 Asia: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 71 Asia: Recombinant Non-Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 72 Asia: Recombinant Glycosylated Proteins Market Size, by Type,  2014-2021 (USD Million)
Table 73 Asia: Recombinant Peptides Market Size, by Type,  2014-2021 (USD Million)
Table 74 Asia: Biosimilars Market Size, by Application, 2014-2021 (USD Million)
Table 75 Asia: Biosimilars Market Size, by Manufacturing Type,  2014-2021 (USD Million)
Table 76 China: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 77 India: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 78 Japan: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 79 South Korea: Biosimilars Market Size, by Product,  2014-2021 (USD Million)
Table 80 Roa: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 81 Row: Biosimilars Market Size, by Product, 2014-2021 (USD Million)
Table 82 Row: Recombinant Non-Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 83 Row: Recombinant Glycosylated Proteins Market Size,  by Type, 2014-2021 (USD Million)
Table 84 Row: Recombinant Peptides Market Size, by Type,  2014-2021 (USD Million)
Table 85 Row: Biosimilars Market Size, by Application, 2014-2021 (USD Million)
Table 86 Regulatory Approvals, 2013-2016
Table 87 Agreements, Collaborations, and Partnerships, 2013-2016
Table 88 Product Launches, 2013-2016
Table 89 Acquisitions, 2013-2016
Table 90 Expansions, 2013-2016
Table 91 Other Developments

List of Figures
Figure 1 Research Methodology
Figure 2 Biosimilars Market: Bottom-Up Approach
Figure 3 Top-Down Approach
Figure 4 Data Triangulation Methodology
Figure 5 Biosimilars Market Size, by Product, 2016 Vs. 2021 (USD Billion)
Figure 6 Biosimilars Market Size, by Type of Manufacturing, 2016 Vs. 2021 (USD Billion)
Figure 7 Biosimilars Market Size, by Application, 2016 Vs. 2021 (USD Billion)
Figure 8 Geographical Snapshot of the Biosimilars Market
Figure 9 Biosimilars Market to Register a High, Double-Digit Growth Rate During the Forecast Period
Figure 10 Recombinant Non-Glycosylated Proteins Segment to Account for the Largest Market Share in 2016
Figure 11 Oncology Segment Will Continue to Dominate the Biosimilars Market in 2021
Figure 12 Asia to Register the Highest Cagr During the Forecast Period
Figure 13 Biosimilars Market: Drivers, Restraints, Opportunities, & Challenges
Figure 14 Global Incidences of Top Ten Cancer
Figure 15 Global Incidences of Diabeties
Figure 16 Biosimilars Market Size, by Product Type, 2014-2021
Figure 17 In-House Manufacturing Segment to Dominate the Biosimilars Market in 2016
Figure 18 Oncology to Dominate the Biosimilars Market in 2016
Figure 19 Global Cancer Incidence, by Region, 2012-2020
Figure 20 Europe to Dominate the Biosimilars Market in 2016
Figure 21 North America: Biosimilars Market Snapshot
Figure 22 Glucagon Segment to Hold the Largest Share of the North American Market
Figure 23 Europe: Biosimilars Market Snapshot
Figure 24 Erythropoietin Segment to Hold the Largest Share of the European Market
Figure 25 Asia: Biosimilars Market Snapshot
Figure 26 Recombinant Non-Glycosylated Proteins Segment to Hold Largest Share of the Asian Market
Figure 27 Oncology Segment to Hold Largest Share in the Asian Market in 2016
Figure 28 Row: Biosimilars Market Snapshot
Figure 29 Granulocyte Colony-Stimulating Factor Segment to Hold Largest Share of the Row Market in 2016
Figure 30 Key Developments Adopted by Market Players Between 2013 and 2016
Figure 31 Global Biosimilars Market Share, by Key Player, 2015
Figure 32 Battle for Market Share: Regulatory Approvals Was the Key Strategy Pursued by Market Players Between 2013 & 2016
Figure 33 Product Benchmarking for the Top 3 Players
Figure 34 Company Snapshot: Pfizer Inc.
Figure 35 Company Snapshot: Sandoz International Gmbh
Figure 36 Company Snapshot: Teva Pharmaceutical Industries Ltd.
Figure 37 Company Snapshot: F. Hoffmann-La Roche Ltd.
Figure 38 Company Snapshot: Amgen Inc.
Figure 39 Company Snapshot: Biocon Ltd.
Figure 40 Company Snapshot: Dr. Reddy's Laboratories
Figure 41 Company Snapshot: Celltrion Inc.
Figure 42 Company Snapshot: Mylan Inc.

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Amgen Inc.
  • Biocon Ltd.
  • Celltrion Inc.
  • Dr. Reddy's Laboratories
  • F. Hoffmann-La Roche Ltd.
  • Mylan Inc.
  • MORE

The global biosimilars market is segmented on the basis of product, manufacturing type, and application. Factors such as rising incidence of various diseases, increasing demand for biosimilar drugs due to their cost-effectiveness, growing pressure to curtail healthcare expenditure, rising geriatric population, strategic collaborations resulting in enhanced productivity and clinical trial activities for biosimilars, and increasing government support and initiatives to develop and promote biosimilars are expected to drive the growth of this market.

Emerging markets and new indications and patent expiry of biologic products has opened an array of opportunities for players in the biosimilars market. However, complexities in manufacturing and innovative strategies by biologic drug manufacturers are expected to restrain the growth of this market to a certain extent during the forecast period.

The biosimilars market is expected to reach USD 10.90 Billion by 2021 from USD 3.39 Billion in 2016, at a CAGR of 26.3%.

On the basis of product, the biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins segment is expected to account for the largest share of the market in 2016. Factors such as new product launches, cost-effectiveness, growing incidence of diabetes, and presence of many biosimilar versions of insulin in the pipeline are driving this market.

On the basis of manufacturing type, the biosimilars market is segmented into in-house manufacturing and contract manufacturing organizations. In 2016, the in-house manufacturing segment is expected to account for the largest share of the market. This growth can be attributed to the increasing demand for biosimilar products owing to the rising incidence of various diseases.

On the basis of application, the biosimilars market is segmented into oncology, blood disorders, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases, and other applications. The oncology segment is expected to grow at the highest CAGR during the forecast period.

Based on region, the biosimilars market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). The market is dominated by Europe, followed by Asia, North America, and the Rest of the World (RoW). However, Asia is expected to witness the highest CAGR during the forecast period. This growth can be attributed to factors such as low per capita consumption, rapid growth in economies, rise in technological innovation, trade links, and the rise in medical tourism.

The key players in the biosimilars market include Pfizer Inc. (U.S.), Sandoz International GmbH (Germany), Teva Pharmaceuticals Industries Ltd. (Israel), Amgen Inc. (U.S.), Biocon Ltd. (India), Dr. Reddy’s Laboratories Ltd. (India), F. Hoffmann-La Roche Ltd. (Switzerland), Celltrion Inc. (South Korea), and Samsung Bioepis (South Korea).

Note: Product cover images may vary from those shown
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  • Amgen Inc.
  • Biocon Ltd.
  • Celltrion Inc.
  • Dr. Reddy's Laboratories
  • F. Hoffmann-La Roche Ltd.
  • Mylan Inc.
  • Pfizer Inc.
  • Samsung Bioepis
  • Sandoz International Gmbh (A Division of Novartis International Ag)
  • Teva Pharmaceutical Industries Ltd.
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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