Biosimilars/Biobetters Pipeline Database - Top Level Data (3/8/2016)
The database only covers recombinant proteins and a few other protein products.
Biosimilar and biobetter U.S. and EU launchable dates (patent expiration and data and market
exclusivity expirations) are reported for all >130 reference products are reported in BIOPHARMA,
"The Reference Products Reference."
Note, in addition to the over 730 biosimilars reported in the pipeline , nearly 200 "biogenerics" in non- and lesser-regulated international commerce are identified and loosely
classed at this top level as "biosimilars."
- total product entries = 1357
- total pipeline products (biosimilars + biobetters) = 1219
- biosimilars = 737
- biobetters = 482
- ref. products = 137
- biogenerics (in dev. countries) = ~200 (classed as biosimilars)
Near-term economic impact 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)
(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 in Europe. Biogenerics are the subset of biosimilars primarily oriented to
lesser-regulated, developing country markets.
The great majority of biogenerics are currently marketeted internationally, with their development 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]
|Epoetin alfa|| 85|
|Insulin and analogs|| 51|
|Interferons (alfa)|| 60|
|Interferons (beta)|| 27|
|Cancer indications|| 418|
|mAbs, mAb fragments || 261|
Note, about 50% of those companies claiming the most biosimilars in their pipeline and/or marketed are
not currently manufacturing to US/EU cGMP standards (due to biogenerics being classed as biosimilars for
top-line data analyses).
Companies With the Largest Biosimilars 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|
Biosimilarspipeline.com Information Resources:
A variety of unique follow-on biopharmaceutical-related information resources are available or
Some related articles by the database author:
- "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
- "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"
- "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
," 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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