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
  • 1,836 product records include 1,099 biosimilars, 567 biobetters, 158 reference products; plus 808 involved company records [as of 6/1/2020]
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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, now archived as "The Reference Products' Reference."  The BIOPHARMA online database includes compiled and estimated U.S. and EU patent and regulatory exclusivity expiration dates (marketability dates) for all reference products.  Ask about bundled discounts to the Pipeline and BIOPHARMA databases.
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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 (10/2019).  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)(10/2019). 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. 

Some Popular Targeted Reference Products
[No. of biosimilars by reference product] (10/2019)
Epoetin alfa 98
Neupogen 69
Interferons (alfa) 141
Insulin and analogs 82
Rituxan 60
Herceptin 69
Humira 50
Avastin 57
Somatropins 43
Enbrel 41
Neulasta 38
Remicade 21
Lantus 17
Cancer indications 590
mAbs, mAb fragments      416
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; 6/2020)

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. 19
Sandoz AG/Novartis AG 18
Bio Sidus S.A. 16
Chemo Group (Grupo Insud ) 16
Dong-A Pharmaceutical. 15
Creative Biomart Inc. 16
UGA Biopharma GmbH 14
LG Life Sciences Ltd. 14
Inbiopro Solutions Pvt Ltd. 14
Biocon Ltd. 14
Dr. Reddy's Labs. 14
BioPartners GmbH (Bioton) 13
Intas Biopharmaceuticals Ltd. 13
Hospira/Pfizer 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. 12
Viropro Inc. 11
BioGenomics Ltd. 11
Siam Bioscience 10
Lupin Ltd. 10
Cassara Biotech 10
Biocad Biotechnological Co. 10
Amgen 10
CinnaGen Inc. 10
Shanghai TheraMabs Bio-tech. Co., Ltd.. 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.).

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

Some biosimilars' articles by the database author:

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