Refers to biologic medications that are highly similar to their reference product as they have no clinically meaningful differences in potency, safety, and purity compared to the reference biologic.
Biosimilars are biologic compounds that contain a highly similar version of the active substance in approved biologic, commonly ref2242ed to as the innovator or reference product.
Biologics are larger, more complex and of higher molecular weight than small molecule medicines.
A biological product approval based on chemical, molecular, and structural similarities to an already approved biological drug, known as the reference drug or originator product.
Only minor differences in clinically inactive components are permitted.
Biologics are complex entities used to treat complicated diseases that includes rheumatoid arthritis, cancer, kidney disease, and febrile neutropenia.
A biological product highly similar to an already approved drug,known as a reference product or originator, which shows no clinically meaningful differences to the reference product in terms of safety, purity and potency.
Biosimilars subject to multifaceted regulatory approval pathways.
Generics require bioequivalence data for approval.
Must show no clinically significant differences in its clinical efficacy and safety profile in comparison with its reference product.
Biosimilar approval process includes analytic studies, preclinical testing in clinical trials to establish and confirm biosimilarity.