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Charting the Global Biosimilar pipeline

Introduction

There are multiple biosimilars in development for a range of therapy areas from cancer and diabetes to ophthalmology and respiratory. High-value mAbs such as Roche's Avastin (bevacizumab), Abbvie's Humira (adalimumab) and Janssen/Merck & Co's Remicade (infliximab) are being targeted by multiple biosimilar developers. But which companies are leading the market? What products are being targeted? Where is development geographically concentrated? What licensing and collaboration opportunities are there?

The answers to these and many other questions can be found in Charting the Global Biosimilars Pipeline. This comprehensive report provides the most detailed evaluation of the biosimilar development landscape worldwide. Rich in tables, charts and statistics, it delivers the critical data you need to understand trends, identify opportunities and assess competitive threats.

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Why this report is important

What the report can do for you

Report contents

Why this report is important

What is the true potential of the much hyped biosimilar market? At present there are 260 biosimilar products which are approved in at least one market – and many of those are first generation products such as hormones. The future, however, is looking more interesting with 188 biosimilars in development, 61 of which are in Phase III trials. The number of high value mAbs for a wide range of conditions has increased. Development continues to be concentrated in countries such as India, China, Bangladesh, Iran and South Korea. In contrast, high development cost, originator defence strategies and more stringent regulatory regimes are pegging back development interest in the US and Europe. In the US there are 6 companies with 8 biosimilars registered . The sector is dominated by originator companies such as Pfizer, Amgen and Merck & Co. Europe is scarcely better with 9 companies and 13 biosimilars registered. The global biosimilar market is maturing both in its scope and ambitions.

Use this report to…

Profile the most active biosimilar companies and their pipelines

Know the development status of biosimilars targeting high-value brands and the companies that are involved

Identify licensing and collaboration opportunities

Assess the clinical trials that are underpinning biosimilar development

Review 61 biosimilar projects in Phase III and anticipate where they will make a market impact

Establish where biosimilar development around the world is concentrated and evaluate the companies driving progress

Report contents at a glance

This detailed 432 page report has been organised to give rapid access to, where relevant and available, the key information

Overview

Biosimilars by therapy area

Biosimilars by product class

Most popular/bestselling biosimilar product candidates

Biosimilars by development stage

Leading biosimilar companies

Biosimilar pipeline by product

BIOSIMILAR PIPELINE BY PRODUCT

Each biosimilar monograph utilises well-structured tables and charts to provide clear view of…

Details provided, where available

Class

Mode of action

Key therapeutic area(s)

Route of administration

Reference product

Originator

RP sales

RP indications

US/EU patent information

Number of companies developing this biosimilar

Summary of biosimilar products in development by status, brand/lab code, company and location

Biosimilar product approvals by territory, molecule, biosimilar company, approval date and biosimilar brand name

Comprehensive summary of clinical trial activity including company, product code, trial code, phase, indication, patients enrolled, and estimated study completion dates

Products analysed

Abatacept

Abciximab

Adalimumab

Aflibercept

Anakinra

Bevacizumab

Certolizumab Pegol

Cetuximab

Daclizumab

Darbepoetin Alfa

Denosumab

Eculizumab

Enoxaparin

Epoetin Alfa

Etanercept

Filgrastim

Follitropin Alfa

Infliximab

Insulin Aspart

Insulin Glargine

Insulin (Human)

Insulin Lispro

Interferon Alfa-2A

Interferon Alfa-2B

Interferon Beta-1A

Interferon Beta-1B

Interleukin-2

Interleukin-11

Omalizumab

Palivizumab

Pegfilgrastim

Peginterferon Alfa-2A

Peginterferon Alfa-2B

Pertuzumab

Ranibizumab

Rituximab

Somatropin

Teriparatide

Tocilizumab

Trastuzumab

Ustekinumab

Vedolizumab

BIOSIMILAR PRODUCTS BY COMPANY

Each company monograph utilises well-structured tables and charts to provide, where relevant and available, a clear view of…

Details provided, where available

Class

Mode of action

Key therapeutic area(s)

Route of administration

Reference product

Originator

RP sales

RP indications

US/EU Patent information

Number of companies developing this biosimilar

Biosimilar development status

Biosimilar brand/lab code

Biosimilar developer(s)

Location of biosimilar developer(s)

Companies analysed

Accord Healthcare

Adello Biologics

Alteogen

Amgen

Apotex

Aprogen

Archigen Biotech

Biocad

Biocon/Mylan

Boehringer Ingelheim

Celltrion

Centus Biotherapeutics

Cipla

Coherus Biosciences

Dem Ilaç

Dr Reddy's

Epirus Biopharmaceuticals

Finox Biotech

Formycon AG

Fresenius

Fuji Pharma

Fujifilm Kyowa Kirin Biologics

Glenmark

Hanwha Chemical

Intas

JCR Pharmaceuticals

JHL Biotech

LG Chem/LG Life Sciences

Lilly

Mabion

mAbxience

Merck & Co

Mochida

Momenta

Nichi-Iko

Nippon Kayaku

Pfenex

Pfizer

Pharmathen

Prestige Biopharma

Reliance Life Sciences

Rovi

Samsung Bioepsis

Sandoz

Sanofi

Stada Arzneimittel

Techdow Europe AB

Teva

Torrent Pharmaceuticals

USV

Wockhardt

YL Biologics

Zydus Cadila


1. Report methodology and objectives
1.1 Key data sources
1.1.1 Clinical trials
1.1.2 Company data
1.1.3 Investment reports
1.1.4 Conference proceedings
1.1.5 Social media
2. Overview
2.1 Biosimilars by therapy area
2.2 Biosimilars by product class
2.3 Most popular/bestselling biosimilar product candidates
2.4 Biosimilars by development stage
2.5 Leading biosimilar companies
3. Biosimilar pipeline by product
3.1 Abatacept
3.2 Abciximab
3.3 Adalimumab
3.4 Aflibercept
3.5 Anakinra
3.6 Bevacizumab
3.7 Certolizumab pegol
3.8 Cetuximab
3.9 Daclizumab
3.10 Darbepoetin alfa
3.11 Denosumab
3.12 Eculizumab
3.13 Enoxaparin
3.14 Epoetin alfa
3.15 Etanercept
3.16 Filgrastim
3.17 Follitropin alfa
3.18 Infliximab
3.19 Insulin aspart
3.20 Insulin glargine
3.21 Insulin (human)
3.22 Insulin lispro
3.23 Interferon alfa-2A
3.24 Interferon alfa-2B
3.25 Interferon beta-1A
3.26 Interferon beta-1B
3.27 Interleukin-2
3.28 Interleukin-11
3.29 Omalizumab
3.30 Palivizumab
3.31 Pegfilgrastim
3.32 Peginterferon alfa-2A
3.33 Peginterferon alfa-2B
3.34 Pertuzumab
3.35 Ranibizumab
3.36 Rituximab
3.37 Somatropin
3.38 Teriparatide
3.39 Tocilizumab
3.40 Trastuzumab
3.41 Ustekinumab
3.42 Vedolizumab
4. Biosimilar pipelines by company
4.1 Accord Healthcare
4.1.1 Product and pipeline status
4.1.2 Product approvals
4.2 Adello Biologics
4.2.1 Product and pipeline status
4.3 Alteogen
4.3.1 Product and pipeline status
4.4 Amgen
4.4.1 Product and pipeline status
4.4.2 Product approvals
4.5 Apotex
4.5.1 Product and pipeline status
4.5.2 Product approvals
4.6 Aprogen
4.6.1 Product and pipeline status
4.7 Archigen Biotech
4.7.1 Product and pipeline status
4.8 Biocad
4.8.1 Product and pipeline status
4.8.2 Product approvals
4.9 Biocon/Mylan
4.9.1 Product and pipeline status
4.9.2 Product approvals
4.10 Boehringer Ingelheim
4.10.1 Product and pipeline status
4.10.2 Product approvals
4.11 Celltrion
4.11.1 Product and pipeline status
4.11.2 Product approvals
4.12 Centus Biotherapeutics
4.12.1 Product and pipeline status
4.13 Cipla
4.13.1 Product and pipeline status
4.14 Coherus Biosciences
4.14.1 Product and pipeline status
4.15 Dem Ilaç
4.15.1 Product and pipeline status
4.16 Dr Reddy’s
4.16.1 Product and pipeline status
4.17 Epirus Biopharmaceuticals
4.17.1 Product and pipeline status
4.17.2 Product approvals
4.18 Finox Biotech
4.18.1 Product and pipeline status
4.18.2 Product approvals
4.19 Formycon AG
4.19.1 Product and pipeline status
4.20 Fresenius
4.20.1 Product and pipeline status
4.21 Fuji Pharma
4.21.1 Product and pipeline status
4.22 Fujifilm Kyowa Kirin Biologics
4.22.1 Product and pipeline status
4.23 Glenmark
4.23.1 Product and pipeline status
4.24 Hanwha Chemical
4.24.1 Product and pipeline status
4.24.2 Product approvals
4.25 Intas
4.25.1 Product and pipeline status
4.25.2 Product approvals
4.26 JCR Pharmaceuticals
4.26.1 Product and pipeline status
4.26.2 Product approvals
4.27 JHL Biotech
4.27.1 Product and pipeline status
4.28 LG Chem/LG Life Sciences
4.28.1 Product and pipeline status
4.29 Lilly
4.29.1 Product and pipeline status
4.29.2 Product approvals
4.30 Mabion
4.30.1 Product and pipeline status
4.31 mAbxience
4.31.1 Product and pipeline status
4.32 Merck & Co
4.32.1 Product and pipeline status
4.32.2 Product approvals
4.33 Mochida
4.33.1 Product and pipeline status
4.33.2 Product approvals
4.34 Momenta
4.34.1 Product and pipeline status
4.35 Nichi-IkoProduct and pipeline status
4.35.1 Product approvals
4.36 Nippon Kayaku
4.36.1 Product and pipeline status
4.36.2 Product approvals
4.37 Pfenex
4.37.1 Product and pipeline status
4.38 Pfizer
4.38.1 Product and pipeline status
4.39 Pharmathen
4.39.1 Product and pipeline status
4.39.2 Product approvals
4.40 Prestige Biopharma
4.40.1 Product and pipeline status
4.41 Reliance Life Sciences
4.41.1 Product and pipeline status
4.41.2 Product approvals
4.42 Rovi
4.42.1 Product and pipeline status
4.43 Samsung Bioepsis
4.43.1 Product and pipeline status
4.43.2 Product approvals
4.44 Sandoz (Novartis)
4.44.1 Product and pipeline status
4.44.2 Product approvals
4.45 Sanofi
4.45.1 Product and pipeline status
4.45.2 Product approvals
4.46 Stada Arzneimittel
4.46.1 Product and pipeline status
4.46.2 Product approvals
4.47 Techdow Europe AB
4.47.1 Product and pipeline status
4.47.2 Product approvals
4.48 Teva
4.48.1 Product and pipeline status
4.48.2 Product approvals
4.49 Torrent Pharmaceuticals
4.49.1 Product and pipeline status
4.50 USV
4.50.1 Product and pipeline status
4.51 Wockhardt
4.51.1 Product and pipeline status
4.52 YL Biologics
4.52.1 Product and pipeline status
4.53 Zydus Cadila
4.53.1 Product and pipeline status
4.53.2 Product approvals

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