definiens: means : ( a ) in respect of a Product sold in the Un ited States, a biological productapproved under the Public Health Service Act 351(k ) that is highly similar to such Product, notwithsta ndingminor differences in clinically inactive components, and for which there are no clinically meaningful differencesbetween the biosimilar and the Product in terms of the safety, purity and potency ; ( b ) in respect of a Productsold in the EU, a biological product approved under Article 10(4 ) of Directive 2001/83 / EC and Section 4, Part II, Annex I to such Directive based on the demonstratio n of the similar nature of such biological medicina l productand Product ; and ( c ) in respect of a Product sold o utside the United States and the EU, a biological p roductapproved under a similar regulatory pathway as in t he United States and in the European Union, if such pathwayexists