This is a rather straightforward database covering follow-on biopharmaceuticals (biosimilars, biobetters,
biogenerics) 'in the pipeline,' i.e., what's in R&D and world markets.
The database includes more relevant products and companies than other sources, but does not include all the rather generic market analysis
included in other much more expensive biosimilars pipeline resources.
Searching the database (actually, 2 relational databases) involves entering query terms in one or more fields on either the Products or
Companies query forms.
All terms are automatically right truncated and ANDed together. For example, 'antib rec' retrieves all records containing the starting character
strings 'monoc...' and 'rec....' in the searched field, including "recombinant antibody" and "recombinant antibodies."
A password is required for full access. Contact the database developer to request a password.
You will need to login again, if you leave the linked database forms.
Data Sources: Essentially, all public/published information sources are continually and have been used for years to compile this database. Plus, information provided by developers is included.
Generally, the database is updated at least quarterly.
author has been following biosimilars/biobetters development since before these terms were adopted, including
from authoring BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
and having developed the first biosimilars/biobetters
pipeline database marketed by FirstWord.
Product records are cumulative, compiled over time, with many reports of biosimilar/biobetters in development being ephemeral, often simply gone or not able to be readily retrieved
after initial reporting, such as information buried within larger articles, on company Web pages or reported at conferences.
Interested in Reference Products? See BIOPHARMA,
now "The Reference Products Reference," with this online database providing access to detailed product monographs, including the most extensive collection of
biosimilar/biobetter U.S. and EU
marketability dates (expirations of patent, data, orphan, etc.
Bundled database subscriptions are available.
Definitions: Fairly standard definitions are used:
- Biosimilars: Products generally on track for approval based on (bio)similarities with an established Reference Product, including both products
receiving biosimilar approvals in major markets, e.g., U.S./EU, and biogenerics in lesser- and non-regulated markets. The query form allows searching of genuine/major market biosimilars vs.
biogenerics in international commerce.
- Biobetters: Products presumed too inherently different (or innovative) than any current reference product to be able to receive major market
biosimilar appproval, with full
a Reference Product's active agent, whether as a chemical substructure, e.g., within a fusion protein or PEGylated conjugate; or physically,
with most of these involving novel delivery systems,
e.g., the same active agent within a matrix to make it implantable or orally administrable.
Product Database Fields
- Full Record: the full records, all searchable/displayable fields. It is often simplest and most effective to just use this field.
- Reference Product: For biosimilars, the identified or presumed reference product (the product used as comparator
for biosimilar approvals); for biobetters, the primary rather similar established product targeted for competition
- Product name (all names): All product and active agent names
- Generic Name: the generic name(s) for the product, based on the active agent; generally the INN/USAN for the active agent.
This database does not use to terribly bad, but all too common, convention of using INNs/USANs/non-proprietary active agent names as product names.
- Trade Name: Company-designated trade name(s), usually trademarks, company codes/names, and other synonyms
- Product Class: [see definitions above]:
Ref. product - major market (US/EU) reference products
- Markets targeted: Is product development targeted currently primarily to major markets or international markets, with this including 'biogenerics.'
- Stage/Phase of dev.: Products are indexed to their current highest stage/phase of development in any country worldwide.
Pending (where filed in U.S. or EU)
Development halted; abandoned
- Companies Involved: Companies involved (with entries in the Companies database); includes the developer and others
involved, including development and marketing partners, CMOs used, etc.
- Indications/indexing: diseases treated; limited to 6-8 of the major approved reference product's indications.
Some other indexing terms are also
used, e.g., "recombinant," "antibody," "pegylation," "fusion protein," etc.
- Recombinant protein?: select "Recombinant" or "Non-recombinant"
- Antibody?: select "monoclonal antibody" if only interested in these products
Company Database Fields: The Company query results page lists links to substantive company records first, followed by cross-reference entries.
- Full Record?: all searchable/displayable fields
- Company Name
- Country: Location of the main headquarters (where profits go), e.g., Genentech, a subsidiary of Hoffmann-La Roche, is indexed as
- Region Continent/region for the company's main headquarters. Choices are: USA, North America ex-USA [Canada];
Latin / South America; Europe; Asia; and Africa.
- Company Products: The main names (generic and trade names) for products which the company is involved with
- Product Classes: The classes of products which thie company is involved with. Choices are Biosimilars, Biobetters and Reference Products.
- Revenue Class: Ranges of known or estimated company annual revenue. Choices are:
- The following fields are also displayed as part of the full record:
Number of Biosimilars: The number of biosimilars which the company is involved with
Number of Biobetters: The number of biobetters which the company is involved with
Number of Ref. Products: The number of reference products which the company is involved with