Charting the Biosimilar and Biobetter Development Pipeline

• Publication date: June 2012
• Report size: 428 pages

Biosimilar development has failed to meet expectations in recent years, but that is set to change. With a new U.S. biosimilars approval pathway imminent, and the expiration of many top-selling biologics on the horizon, existing biosimilar developers and newcomers are highly motivated to invest in the biosimilar field and are turning their attention to more complex bio...

Biosimilar development has failed to meet expectations in recent years, but that is set to change.

With a new U.S. biosimilars approval pathway imminent, and the expiration of many top-selling biologics on the horizon, existing biosimilar developers and newcomers are highly motivated to invest in the biosimilar field and are turning their attention to more complex biologics, such as monoclonal antibodies. Global sales of biologics are projected to reach $200bn in 2014 (from $138bn in 2010), making it a potentially lucrative market for biosimilar developers.

Originator, generics, and biosimilar companies alike need to be informed about the latest development trends and to know the likely patent expiration of marketed products and status of products in development. However, market intelligence has been widely dispersed, making it very difficult for companies to assess potential competition and areas of opportunity, until now.

FirstWord has gathered the very latest intelligence from BIOPHARMA, the Orange Book, literature, industry associations, company websites, and many other secondary sources to provide a single, authoritative guide to currently marketed and in-development biosimilar products.






Report Overview
In Charting the Biosimilar and Biobetter Development Pipeline , you’ll find details of currently marketed biosimilar and biobetter drugs, and all biosimilar and biobetter drugs known to be in clinical development.

Through more than 60 intuitive tables and charts, you will receive unique insights into high-level trends and significant developments, and can easily drill down to details of a specific product or therapeutic area.

Need to know when Drug X will expire? Expiration dates for reference products draw on analysis of products, active agents, and manufacturing processes to go far beyond the Orange Book.

Need to know who is developing biobetters for interferons? Access a complete list with generic and candidate names, developers, reference products, and earliest possible EU/US launch dates.

The report’s author has also included concise commentary throughout, providing valuable context and key insights.

For a complete guide to biosimilars at your fingertips, download Charting the Biosimilar and Biobetter Development Pipeline today.






Key Report Features
More than 60 exclusive tables and charts, offering a complete and illuminating view of the biosimilar pipeline
Up-to-the-minute details of ALL biosimilars/biobetters known to be in development in US and EU markets, with their development status and earliest potential launch dates
Information on international biogenerics that may seek approval as biosimilars/biobetters in US and EU markets
Comprehensive list of reference products, with key sales data and expected patent expiration dates
Detailed analysis of the biosimilar pipeline and market by reference products, therapeutic area, drug class, and compound class
Reports showing the most active companies, regions, and countries
Insights into areas of most intense competition and greatest potential opportunity
Concise commentary highlighting key findings, and providing valuable market intelligence
Definitions of key terms and concepts




Key Benefits

Understand the universe of biosimilar and biobetter development
Get the complete picture of all products in the biosimilar pipeline
Know the latest status on specific biosimilar andbiobetter products of interest to you
Read about the most significant developments in every therapeutic area
Discover the levels of potential biosimilar and biobetter competition by therapy area and drug class
Analyze the size of the threat to your company’s biologic portfolio
Learn which companies are potential future competitors


Key Questions Answered
When is the earliest potential launch for “Biosimilar X”?
What biosimilars are being developed in each therapeutic area, drug class, and compound class?
Which reference products are most targeted by biosimilar and biobetter developers?
Is the reference product sales value the key factor shaping biosimilar development priorities?
Which therapy areas are going to experience the most and fewest biosimilar entries?
Which companies are most active in the biosimilar and biobetter arena?
Which biosimilar companies have been most successful in getting their products onto the market?
How many new biosimilars will be on the market by 2014?

Who Would Benefit From This Report?
Strategic executives at originator, generic, and biosimilar/biobetter development companies, especially in:

Sales and Marketing
Regulatory Affairs
IP and Patent Affairs
Market Research
Research & Development
Business Development
Medical Communications

Biopharmaceutical Industry in the United States

Executive summary
Introduction
Definitions and methodology
> Scope and coverage
> Glossary
> Methodology
> Patents
> Indexing by indication
> Indexing by phase of development
> Nomenclature
Reference products
> Top20 Reference Products
Biosimilars in development
> Biosimilars by earliest potential launch date — US & EU
> Biosimilars by class and earliest potential launch date in the US (total number)
> Biosimilars by class and earliest potential launch date in the EU (total number)
> Biosimilar developers countries and regions
> Biosimilars in development by drug class
> Leading biosimilar companies - number of biosimilar products in portfolio
> Biosimilar development pipelines by compound class and therapy area
Biosimilar development pipelines by compound class
> Immunomodulators
> Interferons
> mAb Immunomodulators
> Cytotoxic mAbs
> Erythropoietin
> G-CSF
> Insulins
> Other Hormones (excluding insulins)
Biosimilar development pipelines by therapy area
> Endocrine and metabolic disorders
> Haematology
> Infectious and Parasitic Disease
> Musculoskeletal disorders
> Neurology
> Neuromuscular diseases
> Obstetrics/gynaecology
> Oncology
> Ophthalmology
Biobetters in development
> Biobetter developments by compound class and therapy area
> Biobetter development by therapy area and stage
> Biobetters by class and earliest potential launch in the US
> Biobetters by class and earliest potential launch in the EU
> Biobetter developers by compound class
Biobetter development pipeline by compound class
> Immunomodulators
> Interferons
> mAb Immunomodulators
> Cytotoxic mAbs
> Erythropoietins
> Others (Enzymes, Blood Clotting Factors)
> Other Hormones (excluding insulins)
Biobetter development pipeline by therapy area
> Autoimmune disease
> Autoinflammatory disease
> Cardiovascular diseases
> Dermatology
> Endocrine and metabolic disorder
> Haematology
> Infectious and parasitic disease
> Musculoskeletal disorders
> Neurology
> Obstetrics/gynaecology
> Oncology
> Respiratory disease
> Wound care
Product profiles