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Global Biosimilars Market Report 2019-2025: Focus on Products, Applications and Regulations - ResearchAndMarkets.com

May 22, 2019

DUBLIN--(BUSINESS WIRE)--May 22, 2019--

The “Global Biosimilars Market - Products, Applications and Regulations” report has been added to ResearchAndMarkets.com’s offering.

Monoclonal Antibodies constitute the single largest product type in the global Biosimilars market, demand for which is estimated at US$4.4 billion in 2018 and is projected to reach US$28.8 billion by 2025. The overall Biosimilars market in 2019 is expected to reach US$10.4 billion.

Cost-effectiveness, increasing geriatric population, rising incidences and prevalence of chronic ailments such as Cancer, Autoimmune Disorders and Diabetes and supportive government regulations and guidelines are some of the factors fueling the biosimilars market. Patent expiry of most of the monoclonal antibody-based biologics drives the biosimilar monoclonal antibody market.

Oncology biosimilar market leads the biosimilars market and is primarily driven by the rising prevalence and incidence of cancer and patent expiry of the expensive biologics. On the other hand, the growth of the biosimilars market is retarded due to insufficient regulatory guidelines, expensive research and development procedures and preference of patented products by the patients, etc.

Research Findings & Coverage

Key Topics Covered:



1.1 Product Outline

1.1.1 Biosimilars Defined

1.1.2 Backdrop

1.1.3 The Biologics Price Competition and Innovation Act (BPCI Act) Data Exclusivity

1.1.4 Steps Involved in Biosimilar Synthesis

1.1.5 Key Regulatory Authorization Pathway - Synopsis

1.1.6 Biosimilars Types Monoclonal Antibodies (mAB or moAB) Production Process Hybridoma Cell Production Therapeutic Applications Erythropoietin (EPO) Functions of EPO Mechanism of Action Synthesis and Regulation Uses in Medicine Granulocyte Colony-Stimulating Factor (G-CSF) Biological Function Genetics Use in Therapeutics Insulin Biosimilar Insulin The Complexity in Producing Biosimilar Insulin Biosimilar Insulins and the Regulatory Environment Surrounding Them The Market for Biosimilar Insulins Interferons Interferon Categorization Functions of Interferons Interferon Alfa Interferon Beta-1a Interferon Gamma Human Growth Hormone Recombinant Human Growth Hormone Managing Growth Disorders Using Recombinant Human Growth Hormone Biosimilars Other Biosimilars

1.1.7 Biosimilars Therapeutic Areas Oncology Biosimilar G-CSF Autoimmune Diseases Blood Disorders Growth Hormone Deficiency (GHD) Growth Hormone Deficiency in Children Infectious Diseases Treatment of Infectious Diseases


2.1 The United States Food and Drug Administration (USFDA)

2.1.1 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

2.1.2 Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

2.1.3 Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

2.2 European Medicines Agency (EMA)

2.3 The World Health Organization (WHO)

2.4 Canada

2.5 South Korea

2.6 China

2.7 India

2.8 Japan

2.9 Mexico

2.10 Brazil

2.11 Argentina


3.1 mAbs - All The Rage In Biosimilars’ New Wave

3.1.1 The Buildup to the Biosimilar Industry

3.1.2 Current Players: A Sneak Preview

3.2 Biosimilars Slashes the Cancer Treatment Cost

3.3 Emerging Markets to Drive Biosimilars Growth

3.4 Asia: A Preferred Manufacturing Hub for Biosimilars

3.5 SPC Manufacturing Waiver Initiated by EU Commission

3.6 Novel mAb’s Purification Approach to Maximize the Biosimilar Production

3.7 Biosimilars and Patent Dance



Adello Biologics (United States)

Amgen Inc. (United States)

AXXO GmbH (Germany)

BIOCAD (Russia)

Biogen, Inc. (United States)

CoherusBioSciences (United States)

Creative BioMart (United States)

Dong-A Socio Group (South Korea)

Dr. Reddy’s Laboratories Ltd. (India)

Eli Lilly and Company (United States)

Genor Biopharma Co., Ltd. (China)

Hetero Drugs Limited (India)

Insud Pharma SL (Spain)

mAbxience SA (Spain)

Intas Pharmaceuticals Ltd. (India)

LG Chem (South Korea)

Lupin Limited (India)

Mylan, Inc (United States)

Nippon Kayaku Co., Ltd. (Japan)

Pfizer, Inc. (United States)

Reliance Life Sciences Pvt. Ltd. (India)

Sandoz International GmbH (Germany)

Shanghai Henlius Biotech, Inc. (China)

STADA Arzneimittel AG (Germany)

Teva Pharmaceutical Industries Limited (Israel)

Wockhardt Limited (India)

Zydus Cadila (India)


Samsung Bioepis Signs Biosimilars Development and Marketing Agreement with C-Bridge Capital

Biosimilar Association of Samsung Bioepis and 3SBio

Kashiv Pharma Renamed as KashivBioSciences After Acquiring Adello Biologics

Japanese Release of Trastuzumab and Agalsidase Beta Biosimilar

Epoetin Alfa and Pegfilgrastim Biosimilars Now Accessible In the US at Considerable Concession

Biosimilars of Insulin Glargine Introduced in South Korea and the UK

CNDA Accepted Review of Adalimumab Biosimilar

Filgrastim Biosimilar Application Submitted to the US FDA

European Commercial Release of Amgevita and Imraldi

MHLW of Japan Received Approval Application for Dual Darbepoetin Alfa Copy Biologics

Evaluation of Adalimumab Biosimilar SB5 by USFDA

Acceptance of Approval Application by CFDA for Adalimumab Biosimilar

Review Acceptance for Mabion CD20 by EMA and Rituxan Expanded the Therapeutic Range

Dr Reddy’s Introduces Hervycta, A Trastuzumab Biosimilar in India

Resubmission of Marketing Approval of Biosimilar Rituximab to FDA by Celltrion

Refusal of Trastuzumab and Rituximab Biosimilars Approval Applications by FDA

Rejection of Rituximab and Trastuzumab of Celltrion/Teva by FDA

Ontruzant Trastuzumab Biosimilar Released in the UK

Commercialization of Trastuzumab Biosimilar in South Korea By Daewoong

Commercial Release of Adalimumab Biosimilar in India by Hetero

Production of Denosumab Biosimilar in Australia

Acceptance of Applications for Adalimumab and Trastuzumab by FDA

USV’s Filing for Pegfilgrastim Accepted by EMA

Acceptance of Pegfilgrastim and Trastuzumab Fillings by EMA

Introduction of Krabeva, a Bevacizumab Biosimilar, in India

Pegfilgrastim Filling Acceptance by EMA

Danish Company Appeals FDA for Clinical Studies Data of Victoza Copy Biologics

Postponement of Pegfilgrastim Biosimilar Approval of Biocon/Mylan by FDA

Acceptance of Pegfilgrastim Biosimilar Filling of Cinfa by EMA

The US Commercial Release of Adalimumab Biosimilar of Amgen After January 2023

Submission of Approval Application by JCR for Agalsidase Beta Biosimilar in Japan

Acceptance of Approval Filing of Filgrastim Biosimilar of Adello by FDA

Application Acceptance of Sandoz’s Rituximab Biosimilar by FDA

Successful Submission of Dual Trastuzumab Biosimilar to the US FDA for Review

Biosimilar Business of Merck Taken Over by Fresenius Kabi

Merck Introduces RENFLEXIS in the US Market

Initiation of Phase III Interchangeability Study of Adalimumab Biosimilar by Boehringer

Acceptance of Regulatory Submission for Rituximab Biosimilar of Celltrion/Teva by FDA

Refusal of Approval Application of Epoetin Alfa Biosimilar of Pfizer by FDA

Registration of Biocad’s Rituximab Biosimilars in Honduras and Bolivia

Re-evaluation of Bevacizumab and Trastuzumab by FDA Advisory Board

Rejection of Pegfilgrastim Biosimilar of Coherus by FDA

EMA Acceptance of Sandoz’s Adalimumab and Infliximab Biosimilars for Re-evaluation

Epoetin Alfa of Pfizer Receives Approval Recommendation from FDA Advisors

Approval Application Acceptance of Fujifilm’s Adalimumab Biosimilar by EMA

Australian Commercial Release of Infliximab Biosimilar in Second half of 2017

Submission of Approval Application in Japan for Trastuzumab Biosimilar

Introduction of Basal Analogue Insulin Biosimilar in Indonesia

Acceptance of Pegfilgrastim Filling of Mylan/Biocon by FDA

Japanese Approval Application Filed for Etanercept Biosimilar

Filing of Biosimilar Adalimumab Application by Boehringer to FDA and EMA As Well

Withdrawal of Biosimilar Pegfilgrastim Application by Sandoz


7.1 Global Biosimilars Market Overview by Product Type

7.1.1 Global Biosimilars Product Types Market Overview by Geographic Region Monoclonal Antibodies Erythropoietin G-CSF Insulin Other Product Types

7.2 Global Biosimilars Market Overview by Therapeutic Area

7.2.1 Global Biosimilars Therapeutic Area Market Overview by Geographic Region Oncology Autoimmune Disorders Blood Disorders Growth Hormone Deficiency Other Therapeutic Areas




Major Market Players


Major Market Players


Major Market Players


Major Market Players

For more information about this report visit https://www.researchandmarkets.com/r/d742r6

View source version on businesswire.com:https://www.businesswire.com/news/home/20190522005380/en/

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Related Topics:Biosimilars and Biosuperiors



SOURCE: Research and Markets

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PUB: 05/22/2019 06:45 AM/DISC: 05/22/2019 06:45 AM


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