Biosimilars are biologic medicines that are highly similar to existing approved biological products, with no clinically significant differences in safety and efficacy.
Patients and their healthcare providers can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar when these products are used as intended. The decision to prescribe a biosimilar should be made by a healthcare provider in consultation with the patient or caregiver.
Rigorous regulatory approval pathways require the biosimilar manufacturer to demonstrate similarity with no clinically meaningful differences to the reference product through an intricate step-wise process.
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