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Biosimilarity

Meaning

Biosimilarity is a regulatory and scientific concept confirming that a subsequent biological product is highly similar to an already approved reference biological product, with no clinically meaningful differences in terms of safety, purity, and potency. This designation is vital for complex protein-based therapeutics, including recombinant hormones and growth factors, ensuring therapeutic equivalence for patients. It provides a pathway for competition once the original product’s patent expires.