Competitor Analysis: Biosimilar & Biosuperior Therapeutic Antibodies - 2016 Update


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This Competitive Intelligence report about Biosimilar & Biosuperior Therapeutic Antibodies updates the competitive landscape of biosimilar therapeutic antibodies as of May 2016. The report evaluates the the first wave of biosimilar recombinant monoclonal antibodies in comparison with the corresponding originator antibodies and biosuperior antibodies against the same target. The report also describes the next wave of potential biosimilar versions of therapeutic antibodies loosing patent protection in the time frame of 2019 – 2023. The report specifically lists for each target the branded products with their 2015 sales and up-side indications in development, as well as biosuperior and biosimilar antibody drug candidates in development.

The report includes a compilation of marketed, approved and currently active projects in research and development of biosimilar and biosuperior therapeutic antibodies against commercially and clinically validated targets relevant for the first wave of biosimilar antibodies (VEGF, TNF, Her2, CD20, EGF-R). Relevant first wave originator therapeutic antibodies are Humira, Enbrel, Remicade, Avastin, Lucentis, Eylea, Herceptin, Rituxan/MabThera and Erbitux. Second generation therapeutic antibodies against these targets such as Symponi, Cimzia, Cyramza, Perjeta, Arrzera are also subject of biosimilar activities.

The report also addresses the slowly emerging second wave of biosimilar antibody activities against originator therapeutic antibodies such as abatacept, alemtuzumab, denosumab, eculizumab, omalizumab, pavilizumab, tocilizumab, and ustekinumab. 

Competitor projects are listed in a tabular format providing information on:

  • Drug Codes,
  • Target/Mechanism of Action,
  • Class of Compound,
  • Company,
  • Product Category,
  • Indication,
  • R&D Stage and
  • additional comments with a hyperlink leading to the source of information.

About Competitor Analysis Series:

The Competitor Analysis Series delivers NO-FRILLS, but concise information about the pipeline of R&D projects for targets, diseases, technologies and companies at low prices. The information is provided in a tabular format and fully referenced.

Table of Content

A) 2015 SALES OF THERAPEUTIC ANTIBODIES

Overview: 2015 Biologics Sales per Class of Products
Overview: 2015 Therapeutic Antibody Sales per Class of Products
Blockbuster Therapeutic Antibodies in 2015
Anti-TNF Antibody Sales in 2015
Cancer Antibody Sales in 2015
Other Anti-Inflammatory Antibody Sales in 2015
Ophthalmic Antibody Sales in 2015
Cardiometabolic & Anti-Infective Antibody Sales in 2015

B) BIOSIMILAR AND BIOSUPERIOR ANTI-TNF ANTIBODIES – 2016 UPDATE

1. Originator Anti-TNF Antibodies
Approved and Marketed Indications of anti-TNF Antibodies in Regulated Markets
2015 SALES OF ANTI-TNF ANTIBODIES
Sales of Anti-TNF Antibodies in Q1/2016
Humira Pipeline of Recently Approved Indications & Upside Developments
Remicade Pipeline of Recent Approvals & Upside Indications
Enbrel Pipeline of Upside Indications
Simponi Pipeline of Recent Approvals & Upside Indications
Cimzia Pipeline of Recent Approvals & Upside Indications
Defense Strategies against Biosimilar Anti-TNF Antibodies
2. Biosuperior Anti-TNF Antibodies
Non-Antibody Anti-TNF Biosuperiors
Anti-TNF Biosuperior Antibodies
3. Biosimimilar Anti-TNF Antibodies
Humira Biosimilar Antibodies:
Developments in Regulated Markets
Developments in Less Regulated Markets
Enbrel Biosimilar Antibodies:
Developments in Regulated Markets
Developments in Less Regulated Markets
Remicade Biosimilar Antibodies:
Developments in Regulated Markets
Developments in Less Regulated Market
Simponi & Cimzia Biosimilar Antibodies

C) BIOSIMILAR AND BIOSUPERIOR ANTI-VEGF/-R ANTIBODIES – 2016 UPDATE

1) Marketed Anti-VEGF/R Products in Oncology
Avastin, Zaltrap & Cyramza Sales 2008 – 2015
Avastin Sales and Indication Portfolio
Zaltrap Sales and Indication Portfolio
Cyramza Sales and Indication Portfolio
2) Anti-VEGF Biosuperiors of Avastin and Zaltrap
Anti-VEGF Biosuperior Pipeline in Oncology
Bispecific Anti-VEGF Pipeline in Oncology
3) Anti-VEGF-R Biosuperiors of Cyramza
Anti-VEGF-R Biosuperior Pipeline in Oncology
Bispecific Anti-VEGF-R Pipeline in Oncology
4) Avastin & Cyramza Biosimilar Pipeline in Oncology
5) Marketed Anti-VEGF Products in Ophthalmology
Lucentis & Eylea Sales 2008 – 2015
Lucentis Sales & Indication Portfolio
Eylea Sales & Indication Portfolio
6) Anti-VEGF Biosuperiors of Lucentis and Eylea
Biosuperior Anti-VEGF in Ophthalmology
Biosuperior Bispecific Anti-VEGF and Anti-VEGF Combinations in Ophthalmology
7) Other Anti-VEGF Molecules in Ophthalmology
8) Lucentis Biosimilars in Ophthalmology
9) Eylea Biosimilars in Ophthalmology
10) Off-Label Use of Anti-VEGF in Ophthalmology

D) BIOSIMILAR AND BIOSUPERIOR ANTI-HER2 ANTIBODIES – 2016 UPDATE

1. 2015 Anti-Her2 Antibody Sales
2. Originator Anti-Her2 Antibodies
Herceptin Approved Indications & Pipeline
Perjeta Approved Indications & Pipeline
Kadcyla Approved Indications & Pipeline
3. Biosuperior Anti-Her2 Antibodies
3RD GENERATION ANTI-HER2 ANTIBODIES
Bispecific Anti-Her2 Antibodies
Anti-Her2 Antibody-Drug Conjugates, Immunotoxins, Immunocytokines & Radiopharmaceuticals
4. Biosimilar Anti-Her2 Antibodies
Herceptin Biosimilar Antibodies
Developments in Regulated Markets
Development in Less Regulated Markets
5. Perjeta Biosimilar Antibodies

E) BIOSIMILAR AND BIOSUPERIOR ANTI-CD20 ANTIBODIES – 2016 UPDATE

1. 2015 Sales of Anti-CD20 Antibodies
2. Originator Anti-CD20 Antibodies
Rituxan/MabThera Approved Indications & Pipeline
Gazyva Approved Indications & Pipeline
Arzerra Approved Indications and R&D Pipeline
Zevalin Approved Indications
3. Biosuperior Anti-CD20 Antibodies
3RD GENERATION ANTI-CD20 ANTIBODIES
Bispecific Anti-CD20 Antibodies
Anti-CD20 Antibody-Drug Conjugates, Immunotoxins & Immunocytokines
4. Biosimilar Anti-CD20 Antibodies
Rituxan/MabThera Biosimilar Antibodies:
Developments in Regulated Markets
Developments in Less Regulated Markets
5. Arzerra Biosimilar Antibodies

F) BIOSIMILAR AND BIOSUPERIOR ANTI-EGF-R ANTIBODIES - 2016 UPDATE

1. Sales of Anti-EGF-R Antibodies
2. Originator Anti-EGF-R Antibodies
Erbitux Approved Indications & Pipeline
Vectibix Approved Indications & Pipeline
Nimotuzumab Approved Indications & Pipeline
Portrazza Approved Indications & Pipeline
3. Biosuperior Anti-EGF-R Antibodies
3RD GENERATION ANTI-EGF-R ANTIBODIES
Bispecific Anti-EGF-R Antibodies
Anti-EGF-R Antibody Drug Conjugates
4. Biosimilar Anti-EGF-R Antibodies
Erbitux Biosimilar Antibodies:
Developments in Regulated Markets
Developments in Less Regulated Markets

G) NEXT WAVE OF BIOSIMILAR ANTIBODIES – 2016 UPDATE

Abatacept Biosimilar Antibodies
Aletuzumab Biosimilar Antibodies
Denosumab Biosimilar Antibodies
Eculizumab Biosimilar Antibodies
Omalizumab Biosimilar Antibodies
Palivizumab Biosimilar Antibodies
Tocilizumab Biosimilar Antibodies
Ustekinumab Biosimilar Antibodies
Biosimilars of Immune Checkpoint Inhibitor Antibodies

H) CORPORATE BIOSIMILAR & BIOSUPERIOR THERAPEUTIC ANTIBODY PIPELINES

COMPENIES MENTIONED IN THE REPORT

3SBio (Shenyang Sunshine Pharmaceutical Co)
AbbVie
AbClon
Ablynx
AET Biotech
Affibody
Affilogic
Affimed Therapeutics
Affitech
Allergan
Alopexx Oncology
Alteogen
Alvogen
Ambrx
Amega Biotech
Amgen
AngioChem
Apexigen
Aprogen
Archemix
AREVA Med
Aryogen
Ascendis Pharma
AstraZeneca (MedImmune)
Avaxia Biologics
AVEO Pharmaceuticals
Axxo
Baliopharm
Baxalta
Bayer
Binex
Bio Farma
biOasis Technologies
Biocad
BioCND
Biocon
Bioeq
Biogen
Bionovis
BioXpress Therapeutics
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Celltrion
Centrose
Ceres Oncology
Chengdu Kanghong Biotech Co.
CIMAB
Cipla
Clearside Biomedical
Coherus Biosciences
Complix
Cristalia
Curaxys
CytomX Therapeutics
Daewoong Pharmaceutical Co
Daiichi Sankyo
Delenex Therapeutics
Dermira
Dong-A ST
Dr Reddy’s Laboratories
Eddingpharma
Eisai
Eli Lilly
EnGenlC
Epirus Biopharmaceuticals
Esperance Pharmaceuticals
Exicure
Ferring Pharmaceuticals
ForSight VISION4
Fosun Pharma
Fujifilm Kyowa Kirin Biologics
Gansu Duyiwei Biological Pharmaceutical Co
Gedeon Richter
Gene Techno Science (GTS)
GenIlac
Genor Biopharma
Glenmark Pharmaceuticals
Gliknik
Glycotope
Green Cross
Halozyme
HanAll Pharmaceuticals
Hanwha Chemical Biologics Business
Harvest Moon Pharmaceuticals
Helvetic BioPharma
Hetero Group
Hyprocell
IBC Generium
Ildong Pharmaceutical
Immune Pharmaceuticals
ImmuneXcite
Immunomedics
Innogene Kalbiotech
Innokeys
Innovent Biologics
Intas Pharmaceuticals
Janssen (Johnson & Johnson)
JHL Biotech
Jiangsu Simcere Pharmaceutical
Jiangsu T-mab Biopharma
Kissei Pharmaceutical
Kyowa Hakko Kirin
LegoChem
LG Life Sciences
Libbs Farmaceutica
Mabion
MabTech
MabXience
MacroGenics
Meiji Seika
Merck (MSD)
Merck Biopharma & HealthCare Biosimilars
Merrimack Pharmaceuticals
Mersana Therapeutics
Merus
Mitsubishi Tanabe Pharma
Mochida
Molecular Partners
Molecular Templates
Momenta Pharmaceuticals
Mundipharm
Mycenax Biotech
Mylan Pharmaceuticals
Nanogen Biopharmaceutical Co
Natco Pharma
Neurotech
Nichi-iko Pharmaceutical
Nippon Kayaku
Novartis (& Sandoz/Alcon)
Oncobiologics
OncoMed Pharmaceuticals
Ophthea
Ophthotech
Orygen Biotecnologia
PanOptica
Paras Biopharmaceuticals
Pfenex
Pfizer (& Hospira)
PharmAbcine
Pharmamar
Pharmapraxis
Pieris Pharmaceuticals
PlantForm
Polpharma Group
Probiomed
Protalix Biotherapeutics
Ranbaxy
Regeneron Pharmaceuticals
Reliance Life Sciences
Roche
Samsung Bioepis (JV of Samsung and Biogen)
Sanofi
Senju Pharmaceutical
Shanghai Biomabs Pharmaceutical
Shanghai Celgen BioPharmaceutical Co
Shanghai Citi Pacific (CO) Guojian Pharmaceutical Co (CPGP)
Shanghai Fudan-Zhangjiang BioPharmaceuticals
Shanghai Henlius Biotech
Shanghai Zhangjiang Biotechnology (ZJ-Bio)
Sirnaomics
Sorrento Biologics/Therapeutics
Spectrum Pharmaceuticals
Stada Arzneimittel
STC Biologics
Syd labs
Symphogen
Synthon Biopharmaceuticals
Taisho Pharmaceutical
Takeda Pharmaceutical Co
TG Therapeutics
Therapeutics Protein International (TPI)
Tillots Pharma
Torrent Pharma
TPG Biologics
Trimer Biotech
Triphase Accelerator
TSH Pharma
Tyrogenex
UCB
Unum Therapeutics
Vaccinex
Valeant Pharmaceuticals
Valor Biotherapeutics
Wuhan YZY Biopharma
Xbrane Biopharma
Xencor
YL Biologics
Yuhan
Zhejiang Huahai Pharmaceutical Co
Zhejiang Medicine
Zova Biotherapeutics
Zydus Cadila
Zymeworks
Zyngenia

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