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A Guide to Biosimilars, Biogenerics and Follow-On Biologics

Published by: Informa Healthcare

Published: Sep. 1, 2007 - 237 Pages


Table of Contents


CHAPTER 1 INTRODUCTION
1.1 The advent of biosimilars
1.2 The role of patents in the drug industry
1.3 Protein-based biopharmaceuticals
1.3.1 Background
1.3.2 Manufacturing processes
1.3.3 Protein characterisation
1.3.4 The global market
1.4 Biosimilars
1.4.1 Market drivers and inhibitors
1.4.2 The INN nomenclature system
1.5 Biosimilars regulation
1.5.1 The EU position
1.5.2 US pathways
1.5.2.1 Government initiatives
CHAPTER 2 PRODUCT OVERVIEW
2.1 Introduction
2.1.1 Approved follow-on proteins/biosimilars
2.2 Characteristics of high-selling peptides and proteins
2.2.1 Products with expired patents
2.2.2 Challenging originator’s patents
2.3 Target products for FOB/biosimilar development
2.4 Peptides (NDA Pathway)
2.4.1 Octreotide
2.4.2 Desmopressin
2.4.3 Cyclosporine
2.4.4 Calcitonin
2.4.5 Eptifibatide
2.4.6 LHRH
2.4.7 Bivalirudin
2.4.8 Enfuvirtide
2.4.9 Glucagon
2.4.10 Nesiritide
2.4.11 Teriparatide
2.5 Recombinant non-glycosylated proteins (NDA Pathway)
2.5.1 Insulin
2.5.2 Somatropin
2.5.3 Lepirudin
2.6 Recombinant non-glycosylated proteins (BLA pathway)
2.6.1 Interleukin-2
2.6.2 Interferons
2.6.2.1 Interferon-alfa
2.6.2.2 Interferon-beta
2.6.2.3 Interferon-gamma
2.6.3 Granulocyte-CSF
2.6.4 Interleukin-11
2.6.5 Anakinra
2.6.6 Other proteins
2.7 Recombinant glycosylated proteins (NDA pathway)
2.7.1 Follitropin
2.7.2 Thyrotropin
2.7.3 Urokinase
2.7.4 Glucocerebrosidase
2.7.5 Other products
2.8 Recombinant glycosylated proteins (BLA pathway)
2.8.1 Becaplermin
2.8.2 Granulocyte-macrophage-CSF
2.8.3 Erythropoietin
2.8.4 DNase
2.8.5 Factor VIIa
2.8.6 Factor IX
2.8.7 Factor VIII
2.8.8 Activated protein C
2.8.9 Tissue plasminogen activator
2.8.10 Monoclonal antibodies
2.8.10.1 Chimaeric mAbs
2.8.10.2 Humanised mAbs
2.8.10.3 Human mAbs and fusion proteins
2.8.11 Other proteins
2.9 Strategies of originator companies
2.9.1 Increasing product patent protection
2.9.2 Next-generation branded products
2.9.3 Development of authorised generics
2.9.4 Price reduction of the branded product
CHAPTER 3 APPROACHES TO THE CHARACTERISATION OF BIOSIMILARS
3.1 Introduction
3.2 Problems in characterising biologics
3.2.1 Definitions
3.2.2 Types of biologic
3.2.2.1 Peptides
3.2.2.2 Non-glycosylated proteins
3.2.2.3 Glycosylated proteins
3.2.2.4 Monoclonal antibodies
3.2.3 Equivalence issues
3.2.4 Post-translational modifications
3.2.5 Effect of microheterogeneity
3.2.6 Pharmacokinetics
3.2.7 Pharmacodynamics
3.2.8 Clinical efficacy
3.2.9 Immunogenicity
3.3 Analytical methods
3.3.1 Introduction
3.3.2 Chromatography
3.3.3 Protein sequencing
3.3.4 Mass spectrometry
3.3.5 Nuclear magnetic resonance
3.3.6 Electrophoresis
3.3.7 Western blotting
3.3.8 Bioassays
3.3.9 Other procedures
3.4 Case studies
3.4.1 Introduction
3.4.2 Erythropoietin
3.4.2.1 European position
3.4.2.2 US position
3.4.2.3 Immunogenicity: pure red cell aplasia
3.4.2.4 Immunogenicity: product consistency issues
3.4.3 Somatotropin
3.4.3.1 European position
3.4.3.2 US position
3.4.3.3 Immunogenicity issues
3.4.4 Alpha interferon
3.4.4.1 European position
3.4.4.2 US position
CHAPTER 4 KEY BIOSIMILARS PLAYERS
4.1 Preface
4.2 India-based companies
4.2.1 Biocon
4.2.1.1 Company overview
4.2.1.2 Biosimilar strategy
4.2.1.3 Biosimilar pipeline
4.2.1.4 Biosimilar collaborations
4.2.2 Dr Reddy’s
4.2.2.1 Company overview
4.2.2.2 Biosimilar strategy
4.2.2.3 Biosimilar pipeline
4.2.3 Reliance Life Sciences/Genemedix
4.2.3.1 Company overview
4.2.3.2 Biosimilar strategy
4.2.3.3 Biosimilar pipeline
4.2.3.4 Biosimilar collaborations
4.2.4 Ranbaxy Laboratories
4.2.4.1 Company overview
4.2.4.2 Biosimilar strategy
4.2.4.3 Biosimilar pipeline
4.2.4.4 Biosimilar collaborations
4.3 Germany-based companies
4.3.1 Ratiopharm/Biogenerix
4.3.1.1 Overview
4.3.1.2 Biosimilar strategy
4.3.1.3 Biosimilar pipeline
4.3.1.4 Biosimilar collaborations
4.3.2 Sandoz International (Novartis)
4.3.2.1 Company overview
4.3.2.2 Biosimilar strategy
4.3.2.3 Biosimilar pipeline
4.3.2.4 Biosimilar collaborations
4.3.3 Stada Arzneimittel/Bioceuticals Arzneimittel
4.3.3.1 Company overview
4.3.3.2 Biosimilar strategy
4.3.3.3 Biosimilar pipeline
4.3.3.4 Biosimilar collaborations
4.4 Other EU-based companies
4.4.1 Bioton/Biopartners
4.4.1.1 Company overview
4.4.1.2 Biosimilar strategy
4.4.1.3 Biosimilar pipeline
4.4.1.4 Biosimilar collaborations
4.4.2 DSM (DSM Biologicals)
4.4.2.1 Company overview
4.4.2.2 Biosimilar strategy
4.4.2.3 Biosimilar pipeline
4.4.2.4 Biosimilar collaborations
4.5 US-based companies
4.5.1 Barr Pharmaceuticals/Pliva
4.5.1.1 Company overview
4.5.1.2 Biosimilar strategy
4.5.1.3 Biosimilar pipeline
4.5.1.4 Biosimilar collaborations
4.5.2 Hospira/Mayne Pharma
4.5.2.1 Company overview
4.5.2.2 Biosimilar strategy
4.5.2.3 Biosimilar pipeline
4.5.2.4 Biosimilar collaborations
4.5.3 Dynavax Technologies/Rhein Biotech
4.5.3.1 Company overview
4.5.3.2 Biosimilar strategy
4.5.3.3 Biosimilar pipeline
4.5.3.4 Biosimilar collaborations
4.6 Canada-based companies
4.6.1 Cangene
4.6.1.1 Company overview
4.6.1.2 Biosimilar strategy
4.6.1.3 Biosimilar pipeline
4.6.2 Microbix
4.6.2.1 Company overview
4.6.2.2 Biosimilar strategy
4.6.2.3 Biosimilar pipeline
4.6.2.4 Biosimilar collaborations
4.7 Other companies
4.7.1 Teva Pharmaceutical Industries/Sicor
4.7.1.1 Company overview
4.7.1.2 Biosimilar strategy
4.7.1.3 Biosimilar pipeline
4.7.1.4 Biosimilar collaborations
CHAPTER 5 MARKETS FOR BIOSIMILARS
5.1 Introduction
5.2 Leading drug classes
5.3 Major players
5.4 Market outlook
5.5 Pricing of biosimilars
5.6 Profitability of biosimilars
5.7 Substitutability and interchangeability
5.8 World pharmaceutical market overview
5.9 World market for protein biopharmaceuticals
5.10 Approved biosimilar products
5.10.1 US
5.10.2 Europe
5.11 Forecasts by product
5.11.1 Erythropoietin
5.11.2 Insulin
5.11.3 Interferons
5.11.4 Granulocyte colony stimulating factor
5.11.5 Somatotropins
5.11.6 Other proteins and peptides
5.12 Forecasts by Region
CHAPTER 6 TRENDS AND OPPORTUNITIES
6.1 Biosimilars market gaining momentum
6.2 Competing through superior delivery
6.3 Diversifying biosimilar pipelines
6.4 Tackling immunogenicity
6.5 Expanding the range of cell production systems
6.6 Exploring transgenic production systems
6.7 Developing cell-free protein synthesis
LIST OF TABLES
Table 1.1 Leading protein products in
Table 1.2 Leading monoclonal antibody products in 2006
Table 2.1 Peptides (NDA pathway)
Table 2.2 Recombinant non-glycosylated proteins (NDA pathway)
Table 2.3 Recombinant non-glycosylated proteins (BLA pathway)
Table 2.4 Recombinant glycosylated proteins (NDA pathway)
Table 2.5 Recombinant glycosylated proteins (BLA pathway)
Table 2.6 Patents - peptides (NDA pathway)
Table 2.7 Patents - recombinant non-glycosylated proteins (NDA pathway)
Table 2.8 Patents - recombinant non-glycosylated proteins (BLA pathway)
Table 2.9 Patents - recombinant glycosylated proteins (NDA pathway)
Table 2.10 Patents - recombinant glycosylated proteins (BLA pathway)
Table 2.11 Commercialisation of candidate biosimilars
Table 2.12 Candidate biosimilars by gene target
Table 2.13 Launched peptides and proteins by primary pharmacology description
Table 2.14 Candidate biosimilars (interferon alpha)
Table 2.15 Candidate biosimilars (insulin)
Table 2.16 Candidate biosimilars (erythropoietin)
Table 2.17 Candidate biosimilars (factor VIII)
Table 2.18 Candidate biosimilars (cyclosporin)
Table 2.19 Candidate biosimilars (granulocyte stimulating factor)
Table 2.20 Candidate biosimilars (interferon beta)
Table 2.21 Candidate biosimilars (calcitonin)
Table 2.22 Candidate biosimilars (LHRH)
Table 2.23 Candidate biosimilars (interleukin 2)
Table 2.24 Candidate biosimilars (factor IX)
Table 2.25 Candidate biosimilars (tissue plasminogen activator)
Table 2.26 Candidate biosimilars (urokinase plasminogen activator)
Table 2.27 Candidate biosimilars (follitropin)
Table 2.28 Candidate biosimilars (somatotropin)
Table 2.29 Candidate biosimilars (granulocyte macrophage colony stimulating factor)
Table 2.30 Candidate biosimilars (interferon gamma)
Table 2.31 Candidate biosimilars (octreotide)
Table 2.32 Candidate biosimilars (desmopressin)
Table 2.33 Candidate biosimilars (factor VIIa)
Table 2.34 Candidate biosimilars (protein C)
Table 2.35 Candidate biosimilars (teriparatide)
Table 2.36 Candidate biosimilars (glucocerebrosidase)
Table 2.37 Candidate biosimilars (hirudin)
Table 2.38 Candidate biosimilars (bevacizumab)
Table 2.39 Candidate biosimilars (enfuvirtide)
Table 2.40 Candidate biosimilars (glucagon)
Table 2.41 Candidate biosimilars (interleukin 11)
Table 2.42 Candidate biosimilars (thyrotropin)
Table 2.43 Candidate biosimilars (abciximab)
Table 2.44 Candidate biosimilars (adalimumab)
Table 2.45 Candidate biosimilars (alemtuzumab)
Table 2.46 Candidate biosimilars (anakinra)
Table 2.47 Candidate biosimilars (aprotinin)
Table 2.48 Candidate biosimilars (becaplermin)
Table 2.49 Candidate biosimilars (cetuximab)
Table 2.50 Candidate biosimilars (DNase)
Table 2.51 Candidate biosimilars (efalizumab)
Table 2.52 Candidate biosimilars (eptifibatide)
Table 2.53 Candidate biosimilars (etanercept)
Table 2.54 Candidate biosimilars (gemtuzumab)
Table 2.55 Candidate biosimilars (infliximab)
Table 2.56 Candidate biosimilars (natalizumab)
Table 2.57 Candidate biosimilars (nesiritide)
Table 2.58 Candidate biosimilars (omalizumab)
Table 2.59 Candidate biosimilars (palivizumab)
Table 2.60 Candidate biosimilars (rituximab)
Table 2.61 Candidate biosimilars (trastuzumab)
Table 3.1 Examples of post-translational modifications
Table 3.2 Analytical procedures useful for assessing the equivalence of biotechnological products
Table 5.1 Leading protein drug classes in
Table 5.2 World pharma market by therapeutic category, 2006-2011
Table 5.3 World pharma market by region, 2006-
Table 5.4 Biopharmaceuticals market by application in 2006 and 2011
Table 5.5 Biopharmaceuticals market by company in 2006 and
Table 5.6 Biopharmaceuticals market by protein in 2006 and
Table 5.7 Biosimilars market by protein in 2006 and 2011
Table 5.8 Biopharmaceuticals market by region in 2006 and
Table 5.9 Biosimilars market by region in 2006 and 2011
Table 6.1 Recently published cell-free protein synthesis patents and applications


Abstract

This report will give readers a broad overview of the key drivers and players involved in the biosimilars revolution today. It will also arm readers with the strategic information they need to face the new opportunities presented by this market trend, as well as its challenges.

With regulation playing a key role in the evolving landscape for biosimilar products, the report places particular emphasis on the regulatory situation in two of the largest markets; the US and Europe. While the European regulatory framework for biosimilars is more defined, there have been significant developments in the US too, notably the FDA's approval of Omnitrope, which demostrated that the simplified approval process is available to biosimilars that demostrate comparability with biologics regulated under NDAs. The report discusses the various factors at play in these two markets.

It analyses the situation from the perspectives of both biosimilar manufacturers and innovator companies. For firms looking to develop biosimilars, some 75 proteins and peptide therapeutics were recently identified as potential profitable targets for new products. And significantly, a substantial proportion of these were approved as NDAs, meaning that biosimilar firms can target them knowing that a clear regulatory pathway exists.

Originator companies, meanwhile, are looking to use a range of strategies to delay biogeneric competition; these strategies include patenting preferred formulations, manufacturing methods and protein modifications.

The report will spotlight the most prominent companies in the biosimilars field, not only the well established generics manufacturers but emerging biosimilar developers too. It will also assess the various geographical markets for therapeutic proteins, including North America, Europe and Brazil.

Use this report provides:
  • an overview of the market for therapeutic proteins, including growth factors, anticoagulants, insulins, interferons, hormones, enzymes and vaccines
  • an analysis of the drivers of the nascent biosimilars market and current obstacles to entry
  • a review of the global regulatory situation; essential knowledge for any company looking to introduce biosimilar products to market
  • sales and patent expiry information on the products identified as profitable targets for biosimilars
  • an examination of the issues involved in assessing the similarity of biosimilars and in the prediction of immunogenicity
  • profiles of the most active companies in the biosimilars field
  • their pipelines, business strategies and collaborations in the biosimilars space
  • assessments of factors such as the level of competition, ease of product development and characterisation and the level of patient support required, to predict the market potential for different classes of biosimilars



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