Dalam tantangan publik lainnya, lawan berpendapat bahwa sifat unik dan

kompleks biologis dan hubungan erat antara metode mereka persiapan dan atribut
klinis mengharuskan menggunakan FDA dan mengungkapkan metode manufaktur dan
memproses informasi yang terdapat dalam aplikasi inovator ini. Further, this use and
disclosure would violate Trade Secret and Constitutional Law (Fifth Amendment
taking clause) [17, 18].
The concept of the product is the process may have been applicable to early
biologics, but current capabilities allow the chemical, biologic, and functional
comparison of well - characterized protein drugs. The follow - on manufacturer need
not necessarily utilize the identical method of manufacture or proprietary technology
to reproduce a follow - on biologic with similar clinical safety and efficacy.
Additionally, it is important to distinguish between the regulatory requirements for
approval of an actual generic protein (duplicate of innovator; see discussion below) and
those associated with a 505(b)(2), which requires a showing of similarity between two
products. Any differences between the two would need to be adequately supported by
bridging studies and appropriate clinical and/or nonclinical data.
The FDA has confirmed this interpretation in its response to petitions fi led
regarding FOPs (both in general and targeted to specific applications). The FDA has
clearly said, the use of the 505(b)(2) pathway does not entail disclosure of trade secret
or confidential commercial information, nor does it involve unauthorized reliance on
such data [18].
1.2.5.1 Applicability of 505(j)(1) or ANDA Process to Biogenerics
Biogenerics per se, that is, protein drug products approved via 505(j)(1), would need
to demonstrate their bioequivalence to the innovator protein. However, due to their
complexity and heterogeneity, the classical biopharmaceutical principles upon which
the current ratings of therapeutic equivalence are based do not apply in their current
language to complex macromolecules. For example, due to the nature and complexity
of an immunogenic response, one concern would be if traditional bioequivalence
appropriately addresses the complex safety issues associated with biologics.