Is the EU ready for non-biological complex drug products?

Vlieger, Jon S. B. de; Borchard, Gerrit; Shah, Vinod P.; Flühmann, Beat; Neervannan, Sesha; Mühlebach, Stefan

doi:10.5639/gabij.2016.0503.026

Cited by 3 publications

(1 citation statement)

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“…The FDA uses the NDA pathway for innovators and the ANDA pathway for generics under the Federal Food, Drug, and Cosmetic Act, the BLA pathway for innovator biologics, and the biosimilar or interchangeable licensure pathway under the Public Health Service Act for follow‐on biologics . The EU regulates medicinal products for human use under Directive 2001/83/EC . According to this directive, in order to obtain an authorization to place a medicinal product on the market, marketers shall submit a full application for innovators and an abridged application for generics/hybrids and biosimilars.…”

Section: Current Regulations For Follow‐on Nbcds In the United Statesmentioning

confidence: 99%

Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey

Öner

Michel

Polli

2017

Annals of the New York Academy of Sciences

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Regulatory agencies around the world may have different standards and approaches to evaluate and approve drug products and biological products. We describe the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Act program, as well as their approach to complex products. We discuss regulatory approaches for the development of nonbiological complex drug follow-ons and approval pathways in the United States. We compare FDA policies with other regulatory agencies (i.e., the European Medicines Agency and the Turkish Medicines and Medical Devices Agency). In particular, we describe the policies/pathways across these three agencies to assess equivalence of glatiramer acetate, enoxaparin sodium, and sodium ferric gluconate complex products. We also examine the Turkish market for these selected nonbiological complex drugs.

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Section: Current Regulations For Follow‐on Nbcds In the United Statesmentioning

confidence: 99%