Are ALBUMINEX 5% and ALBUMINEX 25% biosimilars?
No. ALBUMINEX 5% and ALBUMINEX 25% are not biosimilars. ALBUMINEX 5% and ALBUMINEX 25% are approved through the FDA 351(a) process for biologics. Biosimilars are approved through a different process—the 351(k) process.
This can be verified online through the FDA Purple Book Database of Licensed Biological Products website at https://purplebooksearch.fda.gov/advanced-search
- In the Search box, enter: albumin (human)
- This generates a list of all approved albumin (human) products
- Find the column marked “BLA Type” (Biologics License Type)
- Note that all listed albumin (human) products, including ALBUMINEX 5% and ALBUMINEX 25%, have a BLA type of 351(a)
Contact BPL Medical Affairs if a customer requires a more detailed response letter.
What does the suffix kjda mean?
The suffix “kjda” is intentionally without meaning. The suffix is included to meet the FDA guidance for non-proprietary naming of biological products. FDA requires new biologic products approved after 2017 to include a distinguishing suffix that is devoid of any meaning, and comprised of four lower-case letters. Application of the naming convention to biological products licensed under the PHS Act should (1) encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.
This can be verified online through the FDA Nonproprietary Naming of Biological Products Guidance for Industry document at https://www.fda.gov/media/93218/download