BIOPHARMA® :  Biosimilars and Biobetters Pipeline Information
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wwww.BiosimilarsPipeline.com:
Bosimilars/Biobetters Pipeline Databases

New:   The most comprehensive biosimilars and biobetters pipeline reference.  Check out the public/trial databases:
     Products Database
     Companies Database

Authored by this site's Webmaster and the author of BIOPHARMA, the only biopharmaceuticals information resource/reference (at www.biopharma.com).

Some preliminary top level data are presented below.  For further information, please contact the Webmaster, Ron Rader.
See also 2 recent related articles by Mr. Rader:
a) An Analysis of the U.S. Biosimilars Development Pipeline and Likely Market Evolution, BioProcess International, June 2013.
b) Biosimilars in the Rest of the World: Developments in Lesser-Regulated Countries," BioProcessing Journal, Winter 2013/2014

Biosimilars/Biobetters Pipeline Database - Preliminary Top Level Data 3/24/2014)

  • total product entries = 1155
  • biosimilars = 588
  • biobetters = 434
  • total pipeline products (biosimilars + biobetters) = 1022
  • ref. products = 133
Note, this study only covers recombinant proteins and a few other protein products. Vaccines, blood-derived, cultured cells and tissues and other types of biologics are not included!  US/EU-marketed biologics lacking any know biosimilars or biobetters in development are also excluded.  Biosimilar and biobetter U.S. and EU launchable dates (patent expiration and data and market exclusivity expirations) are reported for all 133 reference products.

This includes over 40, nearly all recombinant, mostly monoclonal antibody, products with over $1 billion/year sales, and about 20 others with sales over $500 million/year.

Follow-on products containing rather (bio)similar active agents are classed as either biosimilar (much the same, including approvable as biosimilars) or biobetter (too different to be approved as a biosimilar).  There are still relatively few genuine biosimilars (by US/EU standards), i.e., products approved by a formal biosimilar mechanism, mostly those in Europe.  Biogenerics are the subset of biosimilars primarily oriented to lesser-regulated, developing country markets.  About 66% of biogenerics are currently marketeted internationally, with their pipeline rather small compared to major market-oriented biosimilars.

Note, multiple companies can be involved with each product.

Some Popular Targeted Reference Products
[No. of biosimilars by reference product]
Humira 17
Remicade 9
Epoetin alfa 90
Neupogen 54
Neulasta 16
Enbrel 21
Rituxan 37
Herceptin 31
Lantus 7
Avastin 16
Insulin and analogs 38
Interferons (alfa) 49
Interferons (beta) 26
Somatropins 23
Cancer indications 332
mAbs, mAb fragments      177

Companies With the Largest Biosimilars and Biobetters Pipelines
Biosimilars (10 or more)
Harvest Moon Pharmaceuticals USA, Inc. 28
BioXpress Therapeutics S.A. 19
Zydus Cadilla Healthcare Ltd. 17
Biocon Ltd. 17
Mylan Labs. 14
Inbiopro Solutions Pvt Ltd. 14
Creative Biomart Inc. 13
Green Cross Corp. 12
Bio Sidus S.A. 12
AXXO GmbH 12
Dong-A Pharmaceutical. 12
Bioton S.A.. 11
Chemo Group (Grupo Insud ) 11
Novartis AG 10
LG Life Sciences Ltd. 10
Amega Biotech 10
Cassara Biotech 10
Biobetters (7 or more)
Novo Nordisk A/S 18
Biogen Idec 14
Lilly, Eli & Co. 13
Bolder BioTechnology, Inc. 12
Roche/Genentech 12
Merck KGaA 10
PROLOR Biotech, Inc. 9
Baxter 8
Pfizer Inc. 8
Flamel Technologies 7

Contact information:

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Need a Consultant With Biosimilars Expertise? - The Web master, Ronald A. Rader, is available.  See his short bio and full resume. Mr. Rader is the author of BIOPHARMA, the only information resource/reference specializing in biopharmaceuticals (see www.biopharma.com), has authored the defining articles concerning biopharmaceuticals and biosimilars/FOBs (e.g., see the "What is...", "(Re)Defining" and related abstracts/links above), and is a world-class expert concerning biopharmaceutical information, products, techologies, and related market, technology and policy assessments. 
Sponsors needed!   Without financing and/or collaboration with a view towards the long term, we (Biotech. Info. Inst.) do not foresee commercial viability for our solely developing biosimilar information resources. There simply are too few involved with too few opportunities for cost-recovery, much less profit; and there are no plans to devalue this site by taking advertising. Thus, corporate or other funding or collaboration is needed. We envision developing the best (or only) Web site/database/reference providing substantive authoritive, including (bio)technical, information about biosimilars (and biobetters and biogenerics). To learn more, contact Ron Rader.