Biosimilars/Biobetters Pipeline Database - Top Level Data (as of 1/18/2017)
The Biosimilars/Biobetters Pipeline Directory only covers recombinant proteins (great majority) and other cell culture/fermentation-manufactured protein products.
- product entries = 1454
- pipeline products (biosimilars + biobetters) = 1306
- biosimilars = 797
- biobetters = 507
- ref. products = 146
- companies = 669
[Note, biosimilar and biobetter U.S. and EU launchable dates (patent, data and market
exclusivity expirations) are reported for the >145 reference products in BIOPHARMA,
"The Reference Products Reference]."
Follow-on products containing rather (bio)similar active agents are classed as either:
- Biosimilar - products that are much the same, including products on-track for approval or approved by formal biosimilar mechanisms (in highly-regulated countries/major markets), generally with GMP manufacture and rigorous biosimilarity analyatical and clinical testing.
- Biobetter - products that are too different compared to other approved products to be approved as biosimilars; generally includes something innnovative or different vs. its reference and other similar producs; generally with GMP manufacture and rigorous biosimilarity analyatical and clinical testing
- Biogenerics - subset of biosimilars primarily marketed in
lesser- and non-regulated developing country markets; generally not on-track for approval or approved by formal biosimilar mechanisms; generally not with GMP manufacture and rigorous biosimilarity testing and trials).
Near-term economic impact includes biosimilars sooner or later for the ~45, 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 their numbers of associated biosimilars and biobetters.
Note, multiple companies can be involved with each product.
Some Popular Targeted Reference Products
[No. of biosimilars by reference product]
|Epoetin alfa|| 81|
|Insulin and analogs|| 61|
|Interferons (alfa)|| 63|
|Interferons (beta)|| 29|
|Cancer indications|| 455|
|mAbs, mAb fragments || 291|
Companies With the Largest Biosimilars Pipelines (10 or more)
|Harvest Moon Pharmaceuticals USA, Inc.|| 28|
|Bioviz Technologies Pvt. Ltd.|| 25|
|BioXpress Therapeutics S.A.|| 20|
|Reliance Life Sciences Pvt. Ltd.|| 18|
|Creative Biomart Inc.|| 15|
|Dong-A Pharmaceutical.|| 15|
|Inbiopro Solutions Pvt Ltd.|| 14|
|LG Life Sciences Ltd.|| 14|
|Mylan Labs.|| 14|
|Bio Sidus S.A.|| 12|
|Biocon Ltd.|| 13|
|Chemo Group (Grupo Insud )|| 13|
|Dr. Reddy's Labs.|| 13|
|AXXO GmbH || 12|
|Amega Biotech|| 11|
|BioGenomics Ltd.|| 11|
|Green Cross Corp.|| 11|
|Sandoz AG/Novartis AG|| 11|
|SciGen Ltd. (Bioton)|| 11|
|Viropro Inc. || 11|
|BioPartners GmbH (Bioton)|| 11|
|Cassara Biotech|| 10|
|Intas Biopharmaceuticals Ltd.|| 10|
|Zydus Cadilla Healthcare Ltd.|| 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:
- "Future Manufacturing Strategies for Biosimilars,"
BioProcess International, May 2016, 14(5), p. 24-29
- "Biosimilars Outsourcing and Capacity,"
Contract Pharma, May 2016
- "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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