The same route of administration, dosage form, and the strength of the biological product ?
According to the U.S. FDA-
“A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”
Detailed info about biosimilars can be found at- https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
yes. As pk profile is matched in phase I (Bioequivalence)of clinical trial. Clinical efficacy is compared in subsequent phases.
If developed to the standards of the FDA, and EMA, the answer is 100% "yes." Products with the same structure and function will have the same effect. Head-to--head comparisons of reference and biosimilars are required at multiple levels to confirm the match in clinically important parameters. That having been said, there are products available in less developed countries that claim to be biosimilars but are not developed to the same standards and may not match the structure of the reference. Some of these products are still OK in terms of safety and efficacy (although I would not call them "biosimilars"), but others less so.
As said before , it should be work similarly but nevertheless some countries have loose rules regarding the bioequivalence tests between the drug reference and its biosimilar. Some discrepancies up to 20% are allowed , it should not be though.
A reference product is the single biological product, already approved by FDA, against which a proposed biosimilar product is compared
A biosimilar is a biological product that is highly similar and has no clinically meaningful differences from an existing FDA-approved reference product Biosimilars can have side effects, which are expected to be the same as those of the reference product. FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations for all biologicals. This is to ensure that manufacturers produce biological products with consistent clinical performance.
So technically both products are similar but not exactly the same. There can a minor variation between them without significant clinical consequences.
Biosimilars are expected to go through the same manufacturing process as the reference product and must pass standards that compare the protein structures (must be similar) and mechanism of action (must be the same) to assure that there are no clinically meaningful differences
Hi
As you said " .... technically both products are similar but not exactly the same...."
but :-)
please remember that batches of reference product are technically only similar but not exactly the same as well..... :-) this is why biosimilars cant be identical with reference drug .....
In consequence this statement below cover not only biosimilars but could be applied for reference products as well.
"Because biosimilars are made in living organisms there may be some minor differences from the reference medicine. These minor differences are not clinically meaningful, i.e. no differences are expected in safety and efficacy. Natural variability is inherent to all biological medicines and strict controls are always in place to ensure that it does not affect the way the medicine works or its safety."
Ref:
https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
How similar "only"... could be batches of reference product please download:
Article Drifts in ADCC-related quality attributes of Herceptin®: Imp...
Article Key considerations in the preclinical development of biosimilars
"These minor differences are not clinically meaningful, i.e. no differences are expected in safety and efficacy." like in case biosimilars :-)
Best regards
Tomasz
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