Biosimilars/Biobetters Pipeline Directory        
The most comprehensive and cost-effective follow-on biopharmaceuticals (biosimilars, biobetters and biogenerics) pipeline resource 

  • Find competing products and companies; product/API licensing sources; collaborators and partners; customers for your products, technologies and services
  • Over 1,750 product records:  1,030+ biosimilars, 560+ biobetters, 150+ reference products; plus 780+ involved company records [1/1/2019]
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  • Developed by the author of BIOPHARMA:  Biopharmaceutical Products in the U.S. and European Markets, still the only information resource/reference specializing in biopharmaceuticals, but now archived as "The Reference Products' Reference."  This online database includes compiled and estimated patent and regulatory exclusivity expiration dates for all reference products. Ask about bundled discounts to the Pipeline and BIOPHARMA (Reference Products) databases.
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Biosimilars/Biobetters Pipeline Directory - Top Level Data (as of 1/1/2019)

  • product entries = 1,754
  • pipeline products (biosimilars + biobetters) = 1,598
  • biosimilars = 1,032
  • biobetters = 566
  • ref. products = 156
  • companies = 782 (in separate relational database)
The Biosimilars/Biobetters Pipeline Directory covers only recombinant (great majority) and other cell culture/fermentation-manufactured protein 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 includes biosimilars sooner or later in the U.S. and European markets for the ~50, 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 the numbers of biosimilars and biobetters associated with companies based (with headquarters) in these countries/regions.  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 more biogenerics vs. biosimilars in more highly-regulated markets).  China will soon surpass India in terms of biosimilars, while currently 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. Product entries are indexed and the online database allows searching of products, including prospective genuine biosimilars, being developed initially or primarily for highly-regulated country markets (>400 products) vs. biogenerics (>700; usually called 'biosimilars' by their developers).
      Note, nearly all of the 'marketed biosimilars' (>325) 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 tested analytically and clinically in comparison with their reference product. Biogenerics are often sold in lesser- and non-regulated international commerce based simply on meeting pharmacopeial standards for the reference product; including often sold through tenders/RFPs (essentially order from a company acting as a CMO). With work, biogenerics may become approvable as biosimilars in highly-regulated countries.

Some Popular Targeted Reference Products
[No. of biosimilars by reference product]
Epoetin alfa 96
Neupogen 66
Interferons (alfa) 129
Insulin and analogs 81
Rituxan 52
Herceptin 66
Humira 50
Avastin 54
Somatropins 43
Enbrel 40
Neulasta 36
Remicade 21
Lantus 17
Cancer indications 574
mAbs, mAb fragments      402
The table above shows the number of biosimilars (not including biobetters) targeted to some popular reference products and product classes.

Companies With the Largest Biosimilars Pipelines (10 or more)

Harvest Moon Pharmaceuticals USA, Inc. 28
Bioviz Technologies Pvt. Ltd. 25
Pfizer 21
BioXpress Therapeutics S.A. 20
Reliance Life Sciences Pvt. Ltd. 19
Mylan Labs. 18
Sandoz AG/Novartis AG 17
Chemo Group (Grupo Insud ) 15
Dong-A Pharmaceutical. 15
Creative Biomart Inc. 15
UGA Biopharma GmbH 14
LG Life Sciences Ltd. 14
Inbiopro Solutions Pvt Ltd. 14
Dr. Reddy's Labs. 14
Bio Sidus S.A. 14
Intas Biopharmaceuticals Ltd. 13
Hospira/Pfizer 13
Biocon Ltd. 13
Zhejiang HISUN Pharmaceuticals Co. Ltd./3S Bio. 12
SciGen Ltd. (Bioton) 12
GC Corp./Green Cross Corp. 12
AXXO GmbH 12
Amega Biotech 12
Zydus Cadilla Healthcare Ltd. 11
Viropro Inc. 11
BioGenomics Ltd. 11
Siam Bioscience 10
Lupin Ltd. 10
Cassara Biotech 10
Biocad Biotechnological Co. 10
Amgen 10
Companies with the largest biosimilars portfolios (not including biobetters) are shown above. Note, multiple companies are often involved with a product (developers, partners, licensees, CMO manufacturers, etc.). Information Resources A variety of unique follow-on biopharmaceutical-related information resources are available or planned:

Some related articles by the database author:

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