Biosimilars/Biobetters Pipeline Database - Top Level Data (as of 1/18/2017)

• product entries = 1454
• pipeline products (biosimilars + biobetters) = 1306
• biosimilars = 797
• biobetters = 507
• ref. products = 146
• companies = 669

The Biosimilars/Biobetters Pipeline Directory only covers recombinant proteins (great majority) and other cell culture/fermentation-manufactured protein products. 
[Note, biosimilar and biobetter U.S. and EU launchable dates (patent, data and market exclusivity expirations) are reported for the >145 reference products in BIOPHARMA, "The Reference Products Reference]." 
Follow-on products containing rather (bio)similar active agents are classed as either:

• Biosimilar - products that are much the same, including products on-track for approval or approved by formal biosimilar mechanisms (in highly-regulated countries/major markets), generally with GMP manufacture and rigorous biosimilarity analyatical and clinical testing. 
• Biobetter - products that are too different compared to other approved products to be approved as biosimilars; generally includes something innnovative or different vs. its reference and other similar producs; generally with GMP manufacture and rigorous biosimilarity analyatical and clinical testing 
• Biogenerics - subset of biosimilars primarily marketed in lesser- and non-regulated developing country markets; generally not on-track for approval or approved by formal biosimilar mechanisms; generally not with GMP manufacture and rigorous biosimilarity testing and trials). 

Near-term economic impact includes biosimilars sooner or later for the ~45, nearly all recombinant, mostly monoclonal antibody, products with over $1 billion/year sales, and 20+ others with sales over $500 million/year. 

The table above shows country or regions and their numbers of associated biosimilars and biobetters.

Note, multiple companies can be involved with each product.

Biosimilarspipeline.com Information Resources:  A variety of unique follow-on biopharmaceutical-related information resources are available or planned:

• Biosimilars/Biobetters Pipeline Database:  see above and left column
• BIOPHARMA:  Biopharmaceutical Products in the U.S. and European Markets - the only information resource specializing in biopharmaceuticals; "The Reference Products Reference"
• Glossary of Biosimilar and Biobetter-Related Terms - simple definitions
• Biosimilar terminology and definitions - background about terminology and definitions
• U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products:  biosimilars, biobetters and other biopharmaceutical product and agent nomenclature and registries (planned)
• Licensing Opportunities - products, technologies and patents (planned)
• Product Documentation Library - descriptive product information from the only fully authoritative sources - manufacturers and regulatory agencies (planned)
• News/Blog - miscellaneous news and commentary (planned)

Some related articles by the database author:

• "Future Manufacturing Strategies for Biosimilars," BioProcess International, May 2016, 14(5), p. 24-29
• "Biosimilars Outsourcing and Capacity," Contract Pharma, May 2016
• "An Analysis of the U.S. Biosimilars Development Pipeline and Likely Market Evolution," BioProcess International, June 2013
• "Biosimilars in the Rest of the World: Developments in Lesser-Regulated Countries," BioProcessing Journal, Winter 2013/2014
• "Nomenclature of Biosimilars Will Be Highly Controversial" , BioProcess International, June 2011
• "FDA Biosimilars/Biopharmaceuticals Naming Proposal Fails on Basic Principles and Incoherency
• "Biosimilars Impacting CMO Capacity" - from Pharmaceutical Outsourcing
• "Biopharma Nomenclature:  Citizen Petition Requests Biopharmaceutical Names and Information Be Disclosed by FDA," Contract Pharma [guest editorial].
• "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?  Part 1:  Introduction and Basic Paradigms Introduction and Basic Paradigms" , BioProcess International, March 2007
• "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?  Part 2:  Information, Nomenclature, Perceptions, and the Markets" , BioProcess International, March 2007
• "Re(Defining) Biopharmaceutical ," Nature Biotechnology, July 2008
• "What is a Biopharmaceutical? Part 1: (Bio)Technology-Based Definitions," BioExecutive, March 2005
• "What is a Biopharmaceutical?  Part 2:  Company and Industry Definitions," BioExecutive, May 2005
• "Nomenclature and Registry Systems for Biopharmaceuticals, Biosimilars and Biogenerics"
• "Biopharmaceuticals: Lack of Information Disclosure Confounds Public Trust, Particularly in the Context of Biosimilars" - guest editorial, BioWorld Perspectives

Need a Consultant With Biosimilars Expertise? - Contact Biotechnology Information Institute for world-class expertise concerning biopharmaceutical information, products, technologies, and related market, technology and policy assessments.

Contact information:

Sales handled by: 

BioPlan Associates, Inc.
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Rockville, MD 20850
Tel:  301-921-5979
Fax:  301-926-2455
Email:  biosimilars@bioplanassociates.com

Have a question about content, the databases or PDF?; Contact the author; user support is available M-F, 9AM-5PM, Eastern U.S. time: 
Ronald A. Rader
President
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Phone: 301-424-0255
E-mail: biosimilars@comcast.net

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