Biosimilars/Biobetters Pipeline Directory - Top Level Data (as of 6/1/2020)

• Pipeline products (biosimilars + biobetters) = 1,666 entries
• biosimilars = 1,099 entries
• biobetters = 567 entries
• ref. products = 158 entries
• companies = 808 entries[in linked relational database]

The Biosimilars/Biobetters Pipeline Directory covers only recombinant and other cell culture/fermentation-manufactured therapeutic products.  Vaccines, blood/plasma-derived, cellular and gene therapy products not included. 
[Note, biosimilar and biobetter U.S. and EU launchable dates (patent, data and market exclusivity expirations) are reported for the reference products in BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, "The Reference Products' Reference]." 

Near-term economic impact of biosimilars, the sum of recent annual worldwide revenue for reference products that theoretically become marketable in the U.S. each year, is shown in the above figure.  Economic impact includes biosimilars (and often biobetters too) sooner or later entering the U.S. and European markets for the ~50, nearly all recombinant, mostly monoclonal antibody, products with over $1 billion/year sales, and the 20+ others with sales over $500 million/year. 

The table above shows country or regions and the numbers of biosimilars and biobetters associated with companies based (with headquarters) in these countries/regions (6/2020).  The U.S. is by far the leader in both biosimilars and biobetters.  As a region/continent, Asia is by far the leader in biosimilars (although most are biogenerics vs. biosimilars).  China has now pulled ahead of India in terms of biosimilars in the pipeline, while also having many more biobetters in the pipeline vs. India.

The table above shows the distribution of products by their highest phase of development attained in any country (with phase in the U.S. and Europe also searchable)(6/2020). Product entries are indexed and the online database allows searching of products, including prospective genuine biosimilars, being developed initially for highly-regulated country markets (~1,050 products) vs. biogenerics (>800; usually called 'biosimilars' by their developers) initially targeted to lesser- and non-regulated countries (with 33 products indexed as targeting both markets).
      Note, most of the 'marketed biosimilars' in developing markets are biogenerics -- finished products that are rather similar (e.g., same generic API-based names used) to established major market reference products, but are not manufactured to highly-regulated country (e.g., U.S., EU) GMP standards and/or are or will not be rigorously (by highly-regulated country standards) tested analytically and clinically in comparison with their reference product. 

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

• 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"
• U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products:  biosimilars, biobetters and other biopharmaceutical specific and generic product and agent nomenclature/identifiers and registry system (planned)
• Biosimilar/Biobetter Facilities Directory - to be a subset of the Top 1000 Biopharmaceutical Facilities Index
• Glossary of Biosimilar and Biobetter-Related Terms - simple definitions
• Biosimilar terminology and definitions - background about terminology and definitions
• 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 biosimilars' articles by the database author:

• "Biosimilars Pipeline Shows Remarkable, Sustained Growth," BioProcess Online (and Biosimilar Development), Guest Column, March 7, 2019.
• "Biosimilars Paving The Way For Cost-Effective Bioprocessing," Biosimilar Development, Aug. 23, 2017.
• "Biosimilars and Biobetters: Impact on Biopharmaceutical Manufacturing and CMOs," in Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development, by Liu, C. and Morrow, J., Wiley, Dec. 2016.
• "Biosimilars Pipeline Analysis: Many Products, More Competition Coming", Biosimilar Development, July 26, 2016
• "Future Manufacturing Strategies for Biosimilars," BioProcess International, May 2016, 14(5), p. 24-29
• "Biosimilars Outsourcing and Capacity," Contract Pharma, May 2016
• "Biosimilars Improving Efficiency, Costs for All Biologics,," Contract Pharma, April 2015, p. 28-30.
• "Biosimilars Impacting CMO Capacity," Pharmaceutical Outsourcing, Jan./Feb. 2015, p. 22-16.
• "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
• "Biosimilars and Biobetters," PharmaPro: News, Views, & Technology for the Industry, Jan. 14, 2013.
• "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

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