Biosimilars/Biobetters Pipeline Database - Top Level Data (as of 1/1/2018)
- product entries = 1,600
- pipeline products (biosimilars + biobetters) = 1,552
- biosimilars = 877
- biobetters = 526
- ref. products = 149
- companies = 700
The Biosimilars/Biobetters Pipeline Directory covers only recombinant proteins (great majority) and other cell culture/fermentation-manufactured protein products (e.g., vaccines, blood/plasma and cellular 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.
Note, multiple companies are often involved with each product (developers, partners, licensees, etc.). Marketed products are here indexed by whether they appear primarily on track for initial or primary marketing in developed or developing country markets.
Some Popular Targeted Reference Products
[No. of biosimilars by reference product]
| Epoetin alfa | 90 |
| Neupogen | 77 |
| Interferons (alfa) | 75 |
| Insulin and analogs | 71 |
| Rituxan | 51 |
| Herceptin | 54 |
| Humira | 45 |
| Avastin | 40 |
| Somatropins | 37 |
| Enbrel | 36 |
| Neulasta | 31 |
| Remicade | 21 |
| Lantus | 15 |
| Interferons (beta) | 32 |
| Cancer indications | 490 |
| mAbs, mAb fragments | 334 |
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Companies With the Largest Biosimilars Pipelines (10 or more)
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| Harvest Moon Pharmaceuticals USA, Inc. | 28 |
| Bioviz Technologies Pvt. Ltd. | 28 |
| Pfizer | 21 |
| BioXpress Therapeutics S.A. | 20 |
| Reliance Life Sciences Pvt. Ltd. | 18 |
| Creative Biomart Inc. | 15 |
| Dong-A Pharmaceutical. | 15 |
| Chemo Group (Grupo Insud ) | 15 |
| Inbiopro Solutions Pvt Ltd. | 14 |
| LG Life Sciences Ltd. | 14 |
| Mylan Labs. | 14 |
| Bio Sidus S.A. | 13 |
| Biocon Ltd. | 13 |
| BioPartners GmbH (Bioton) | 13 |
| Intas Biopharmaceuticals Ltd. | 13 |
| Dr. Reddy's Labs. | 13 |
| AXXO GmbH | 12 |
| Sandoz AG/Novartis AG | 12 |
| SciGen Ltd. (Bioton) | 12 |
| Amega Biotech | 12 |
| BioGenomics Ltd. | 11 |
| Green Cross Corp. | 11 |
| BioGenomics Ltd. | 11 | Zydus Cadilla Healthcare Ltd. | 11 |
| Viropro Inc. | 11 |
| Cassara Biotech | 10 |
| Biocad Biotechnological Co. | 10 |
| Siam Bioscience | 10 |
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Biosimilarspipeline.com Information Resources:
A variety of unique follow-on biopharmaceutical-related information resources are available or
planned:
Some related articles by the database author:
- "Biosimilars Paving The Way For Cost-Effective Bioprocessing," Biosimilar Development, Aug. 23, 2017.
- "Biosimilars Pipeline Analysis: Many Products, More Competition Coming", Biosimilar Development, July 26, 2016.
- "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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