US Food And Drug Administration Issues Equivalence Guideline For Biosimilars Producers
Biotherapeutic medicines are made out of living organisms and cannot be replicated. No generic medicines, which are exact copies of the reference product, can be made. The generic equivalent of a biotherapeutic would be biosimilars, which are highly similar products. The United States Food and Drug Administration has issued a guide to help producers to prove how close their biosimilars are to the biotherapeutics.
