Competitor Analysis: Biosimilar and Biosuperior Anti-TNF Antibodies – 2016 Update

May 2016 | 124 pages | ID: CF8FDA0F233EN
La Merie Publishing

Abstracts

Competitor Analysis: Biosimilar and Biosuperior Anti-TNF Antibodies – 2016 Update

Humira, Enbrel and Remicade were the three best selling blockbuster biologics in the year 2015. Together with Simponi and Cimzia, combined sales of all five anti-TNF antibodies in the year 2015 were US$ 36 bln (+3.9% vs previous year), ahead of combined sales of all cancer antibodies. Marketing of biosimilar versions of Remicade and Enbrel in Europe has commenced and first sales data indicate that originator and biosimilar anti-TNF antibodies compete for new patients, rather than switching during ongoing treatment.

While the commercial impact of biosimilar anti-TNF antibodies in the year 2015 still was controlled, sales data of the first quarter of 2016 show a 30% loss of Remicade sales in Europe (about US$ 150 mln). Thus, an accelerating impact of biosimilar competition in Europe can be expected. After approval of the first anti-TNF biosimilar antibody by the FDA in the US, market launch could take place by end of 2016. Even AbbVie’s ‘135 patent for Humira is going to be reviewed by the Patent Trial and Appeal Board of the US Patent and Trademark office, which ultimately could lead to accelerated loss of Humira market exclusivity.

More than 20 different biosimilar anti-TNF antibodies are in phase III development according to EU and US guidelines in regulated markets. As a consequence, the first companies with limited resources are reconsidering their priorities and are evaluating other options.

This Competitive Intelligence report about Biosimilar and Biosuperior Anti-TNF Antibodies – 2016 Update provides a competitor evaluation in the field of recombinant antibodies targeting tumor necrosis factor (TNF) alpha used to treat inflammatory and autoimmune diseases as of May 201. Purchase of the downloadable pdf report includes a 6-month online access to the data of the report and any updates since the publication date. Credentials to access the database will be sent by e-mail and allow online work with the project data to print or export an individual report.

The report includes a compilation of currently active R&D projects of TNF targeting antibodies for treatment of inflammatory and autoimmune diseases. In addition, the report lists company-specific R&D pipelines of TNF antibodies.

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.

Contents

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

4. CORPORATE ANTI-TNF ANTIBODY BIOSIMILAR & BIOSUPERIOR R&D PIPELINE

COMPANIES MENTIONED IN THE REPORT

AbbVie
AbClon
Ablynx
AET Biotech
Affibody
Affilogic
Alteogen
Alvogen
Amega Biotech
Amgen
Apexigen
Aprogen
Aryogen
Avaxia Biologics
Axxo
Baxalta
Binex
Biocad
BioCND
Biocon
Biogen
Bionovis
BioXpress Therapeutics
Boehringer Ingelheim
Celltrion
CIMAB
Cipla
Coherus Biosciences
Complix
Cristalia
Daewoong Pharmaceutical Co
Daiichi Sankyo
Delenex
Dermira
Dong-A ST
Eddingpharma
Eisai
Epirus Biopharmaceuticals
Exicure
Ferring Pharmaceuticals
Fujifilm Kyowa Kirin Biologics
Gene Techno Science (GTS)
Genor Biopharma
HanAll Pharmaceuticals
Harvest Moon Pharmaceuticals
Hetero Group
Innovent Biologics
Intas Pharmaceuticals
Janssen (Johnson & Johnson)
LG Life Sciences
Libbs Farmaceutica
MabTech
MabXience
Meiji Seika
Merck
Merck HealthCare Biosimilars
Mitsubishi Tanabe Pharma
Mochida
Momenta Pharmaceuticals
Mycenax Biotech
Mylan Pharmaceuticals
Nanogen Biopharmaceutical Co
Natco Pharma
Nichi-iko Pharmaceutical
Nippon Kayaku
Novartis (Sandoz)
Oncobiologics
Orygen Biotecnologia
Pfenex
Pfizer (Hospira)
Pharmapraxis
PlantForm
Polpharma Group
Probiomed
Protalix Biotherapeutics
Ranbaxy
Roche
Samsung Bioepis (JV of Samsung and Biogen)
Shanghai Biomabs Pharmaceutical
Shanghai Celgen BioPharmaceutical Co
Shanghai Citic Pacific (CP) Guojian Pharmaceutical Co (CPGJ)
Shanghai Fudan-Zhangjiang BioPharmaceuticals
Shanghai Henlius Biotech
Shenyang Sunshine Pharmaceutical Co (S3Bio)
Sorrento Biologics
Stada Arzneimittel
Taisho Pharmaceutical
Takeda Pharmaceutical Co
Therapeutics Protein International (TPI)
Tillots Pharma
Torrent Pharma
Trimer Biotech
TSH Pharma
UCB
Xbrane Biopharma
Xencor
YL Biologics
Yuhan
Zhejiang Huahai Pharmaceutical Co
Zydus Cadila
Zyngenia