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A Guide to Biosimilars, Biogenerics and Follow-On Biologics

Informa Healthcare
September 1, 2007
237 Pages - SKU: IFHC1693932

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Countries covered: United States, Europe

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

CHAPTER 1 INTRODUCTION: 1.1 The advent of biosimilars; 1.2 The role of patents in the drug industry; 1.3 Protein-based biopharmaceuticals; 1.4 Biosimilars; 1.5 Biosimilars regulation
CHAPTER 2 PRODUCT OVERVIEW: 2.1 Introduction; 2.2 Characteristics of high-selling peptides and proteins; 2.3 Target products for FOB/biosimilar development; 2.4 Peptides (NDA Pathway); 2.5 Recombinant non-glycosylated proteins (NDA Pathway); 2.6 Recombinant non-glycosylated proteins (BLA pathway); 2.7 Recombinant glycosylated proteins (NDA pathway); 2.8 Recombinant glycosylated proteins (BLA pathway); 2.9 Strategies of originator companies
CHAPTER 3 APPROACHES TO THE CHARACTERISATION OF BIOSIMILARS: 3.1 Introduction; 3.2 Problems in characterising biologics; 3.3 Analytical methods
CHAPTER 4 KEY BIOSIMILARS PLAYERS: 4.1 Preface; 4.2 India-based companies; 4.3 Germany-based companies; 4.4 Other EU-based companies; 4.5 US-based companies; 4.6 Canada-based companies; 4.7 Other companies
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; 5.11 Forecasts by product; 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

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A Guide to Biosimilars, Biogenerics and Follow-On Biologics

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