Countries covered: Global
Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies - and some surprising names - are positioning themselves for market entry.
|
- Foreword
- Executive Summary
- What is a biologic drug?
- What’s in a name?
- Biobetters
- Why are Biosimilars an issue?
- products in the ‘first wave’
- Erythropoietin (Epoetin, EPO)
- What is it?
- Who makes it?
- Summary sales data
- Company-specific sales data
- Procrit/Eprex
- Epogen/Aranesp
- Neorecormon/Epogin
- Current biosimilar activity
- USA
- Europe
- Rest of the world
- Human Growth Hormone (somatropin)
- What is it?
- Who makes it?
- Summary sales data
- Company specific sales data
- Genotropin
- Humatrope
- Norditropin/other Novo Nordisk HGH products
- Nutropin
- Saizen/Serostim
- Bio-Tropin/Tev-Tropin
- Current biosimilar activity
- USA
- European Union
- Rest of the world
- G-CSF
- What is it?
- Who makes it?
- Summary sales data
- Company specific sales data
- Neupogen/Neulasta
- Neutrogin/Granocyte
- Leukine
- Current Biosimilar Activity
- USA
- European Union
- Current biosimilar activity in the rest of the world
- Human Insulin
- What is it?
- Who makes it?
- Summary sales data
- Company specific sales data
- Novo Nordisk recombinant insulin products
- sanofi-aventis recombinant insulin products: Lantus, Apidra
- Current biosimilar activity
- USA
- European Union
- Rest of the World
- Interferon
- What is it?
- Who makes it?
- Summary sales data
- Company specific sales data
- Merck & Co (formerly Schering-Plough) Interferon A (Intron A range)
- Betaseron/Betaferon
- Avonex
- Rebif
- Current Biosimilar Activity
- USA
- European Union
- Rest of the World
- Beyond the First wave
- Etanercept
- Amgen gains new patent for etanercept
- Summary sales data - Amgen (USA & Canada)
- Summary sales data - Pfizer (Outside USA & Canada)
- Current Biosimilar activity
- Monoclonal Antibodies
- Adalimumab
- Summary sales data
- Current Biosimilar activity
- Bevacizumab
- Summary sales data
- Current Biosimilar activity
- Cetuximab
- Summary sales data
- Current Biosimilar activity
- Infliximab
- Summary sales data
- Current Biosimilar activity
- Rituximab
- Summary sales data
- Current Biosimilar activity
- Dr Reddy’s: Reditux
- Trastuzumab
- Summary sales data
- Current Biosimilar activity
- WHY Are biosimilars an issue now?
- Rising cost of healthcare
- Is there a commercially viable market?
- The price reduction of the biosimilar
- Case Study: Biosimilar prices in the UK
- Omnitrope
- G-CSF
- EPO
- Patient population
- Physician & patient acceptance
- Regulatory attitude
- National pricing & reimbursement policies
- Interchangeability and substitutability
- Norway makes biosimilar G-CSF switchable - then changes its mind
- Extent of existing competition
- Originator strategies to counter biosimilars
- Global market size estimates, 2015
- The Regulatory Situation in the USA
- Overview of the US regulatory system
- Hatch-Waxman is not generally applicable to biologics
- The 505(b)(2) route
- Enoxaparin
- Another option: file a full BLA?
- The Development of a US Biosimilar Pathway
- The BCPIA
- Approval will be no guarantee of interchangeability
- Biosimilar market exclusivity
- Reference product data exclusivity
- White House seeks to lower data exclusivity period
- Patent dispute resolution
- User fees
- Implementation of the BCPIA
- Slow progress in 2011
- The Regulatory Situation in Europe
- Regulation of biosimilars
- EMA Guideline Documents
- Regulation of Monoclonal Antibodies
- Regulations in Other Developed Markets
- Australia
- Canada
- Japan
- Singapore
- Regulations in Developing markets
- Why are these markets worth a look?
- Brazil
- India
- Indonesia
- Mexico
- Saudi Arabia
- Thailand
- Vietnam
- Who will be the players in the market?
- Current Market Leaders
- Sandoz
- Omnitrope
- Binocrit
- Zarzio
- Rituximab
- Agreements
- Sandoz’ Biosimilar Sales
- Teva Pharmaceutical Industries
- Tevagrastim/Neutroval
- Rituximab
- Teva’s Biosimilar Sales
- Hospira
- Retacrit
- Nivestim
- Distribution deal with Celltrion
- Pliva sells biosimilar rights and facility to Hospira
- The Indian Biosimilar Industry
- Avesthagen
- AVDESP
- Avent
- Kemwell Biopharma
- BiotechCorp
- Siegfried Biologics
- Intas Pharmaceuticals
- Biocon
- Basalog
- Insugen
- Erypro
- NUFIL
- Other products
- Pfizer and Biocon announce major insulin deal
- Biocon takes 100% control of JV from CIMAB
- Mylan and Biocon announce biosimilar deal
- Biocon buys majority stake in German marketing company
- Cipla
- Mab Pharma/Bio Mabs
- Claris Lifesciences
- Dr Reddy‘s
- Gennova Biopharmaceuticals
- Intas Biopharmaceuticals
- New mAb facility announced
- Intas and Apotex sign G-CSF agreement
- MJ Biopharma
- Reliance Life Sciences
- Shantha Biotechnics
- Wockhardt
- Zenotech Laboratories
- Other Developers: Europe
- BioPartners
- Bioton
- Gedeon Richter
- Mochida
- Stada Arzneimittel
- Selexis
- Stada Arzneimittel
- EPO-zeta gains EU approval
- Other Developers: Asia, Africa, Middle East
- 3SBio
- Bioclones
- Celltrion
- Hikma and Celltrion enter biosimilars agreement for the MENA region
- Egis to distribute Celltrion products
- Cinnagen
- CJ Corp
- Getz Pharma
- Inno Biologics
- LG Life Sciences
- Mycenax Biotech
- Protalix
- Samsung
- SciGen
- Simcere/Shanghai Celgen
- Other Developers: Americas
- Biolex Therapeutics
- Cangene
- Cell Therapeutics
- CIGB
- Elona Biotechnologies
- GTC Biotherapeutics
- Itero Biopharmaceuticals
- Momenta Pharmaceuticals
- Sandoz collaboration
- Baxter joint venture
- Mylan
- Marketing Deal with Biocon
- Three Rivers Pharmaceuticals
- Viropro
- Watson
- Itero and Watson announce rFSH agreement
- ‘Big Pharma’ Companies
- Amgen
- Biogen Idec
- Boehringer Ingelheim
- Merck & Co
- Former Insmed G-CSF products
- Merck discontinues EPO project
- Deal signed for etanercept
- Pfizer
- Insulin deal with Biocon
- Sources
- Directory
- Regulators
- Industry Associations
- Manufacturers
- Index
- INDEX OF TABLES
- Leading EPO Brands, World Sales, 2001-2010 (US$ millions)
- Leading EPO Brands, % Change in Sales, 2002-2010
- Leading EPO Brands, % of Subtotal, 2001-2010
- J&J Sales of Procrit/Eprex, 2001-2010 (US$ millions)
- Amgen Sales of Epogen/Aranesp, 2001-2010 (US$ millions)
- Amgen EPO Patents in the USA
- Roche Sales of Neorecormon/Epogin, 2002-2010 (SwF millions)
- Biosimilar EPO: manufacturers' summary
- Leading HGH Brands, World Sales, 2001-2010 (US$ millions)
- Leading HGH Brands, % Change (US$ sales), 2002-2010
- Leading HGH Brands, % of Subtotal, 2001-2010
- Genotropin Sales, 2001-2010 (US$ millions)
- Humatrope Sales, 2001-2010 (US$ millions)
- Novo Nordisk HGH Sales, 2001-2010 (DKK millions)
- Roche/Genentech HGH Sales, 2001-2010 (US$ millions)
- Merck/Serono HGH Sales, 2001-2010 (US$ millions)
- Biosimilar HGH: Manufacturers' Summary
- Leading G-CSF Brands, World Sales, 2001-2010 (US$ millions)
- Leading G-CSF Brands, % Change 2003-2010
- Leading G-CSF Brands, % of Total, 2002-2010
- Neupogen/Neulasta Sales, 2001-2010 (US$ billions)
- Sales of Neutrogin/Granocyte, 2002-2010 (billion yen)
- Biosimilar G-CSF: Manufacturers' Summary
- Leading Human Insulin brands, World Sales, 2001-2010 (US$ millions)
- Leading Human Insulin Brands, % Change, 2002-2010
- Leading Human Insulin Brands, % of Subtotal, 2001-2010
- Sales of Novo Nordisk Insulin Analogues, 2001-2010 (DKK million)
- Sales of Humulin and Humalog, 2001-2010 (US$000s)
- Biosimilar Human Insulin: Manufacturers' Summary
- Leading Interferon Brands, World Sales, 2001-2010 (US$ millions)
- Leading Interferon Brands, % of Subtotal, 2002-2010
- Sales of Intron A and PEG-Intron, 2002-2010 (US$ millions)
- Sales of Pegasys, 2002-2010 (SwF millions)
- Sales of Betaseron/Betaferon, 2001-2010 (euro millions)
- Sales of Avonex, 2001-2010 (US$ millions)
- Sales of Rebif, 2001-2010 (US$ millions)
- Biosimilar Interferons: Manufacturers' Summary
- Summary, factors in favour of the development of biosimilars
- UK NHS Price Comparison, Omnitrope v other HGH Brands, 2009-11
- UK NHS Price Comparison, Ratiograstim v Neupogen, 2009-11
- UK NHS Price Comparison, EPO 2010
- UK NHS Price Comparison, EPO 2011
- Estimated Global Biosimilar Market Size (EPO, G-CSF and HGH), 2015 (US$ millions)
- CHMP General Biosimilar Guidelines
- Other Relevant General Guidelines
- CHMP Product-Specific Guidelines
- Summary Requirements, Chemical Generic v Biosimilars
- Summary of Biosimilar Manufacturers and Products
- 2010 US$ exchange rates used in this report
More Global Biosimilars Reports
Global Biosimilars Market Forecast to 2015 by
RNCOS
The biosimilars industry has been growing stupendously across the globe for past few years. Increasing healthcare costs and rising aging population are driving the industry, ...
Biosimilars: Current Situation & Future Prospects, Worldwide by
JustPharmaReports.com
The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with ...
Global Biosimilars Industry by
Taiyou Research
Biosimilar is a term used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry ...
Global Biosimilars Market Analysis by
RNCOS
The global biosimilars industry has been growing stupendously since the past few years. Various factors, such as increasing healthcare costs, burgeoning aging population, high pharmaceutical ...
Global Biotechnology Market by
Taiyou Research
Biotechnology has become the foundation on which the pharmaceutical industry and many others are progressing on. The biotech revolution has surpassed the IT revolution as ...
See all reports like this >>
Share this report
Other tasks Related Markets Biosimilars Reports Free Alert Me service Receive bi-weekly email alerts on new market research Sign Up Today!
|
