PaxSafe's Mark Talens on why pharma supply chain AI fails before it starts — and the data foundry framework that changes that.
|Articles|April 29, 2015
FDA Releases Final Biosimilar Guidance
Author(s)News Update
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
Advertisement
FDA released final guidance documents on biosimilar products on Apr. 28, 2015. The three documents are:
The documents address comments from various industry perspectives and, according to FDA, “are intended to provide predictability and to make clear the scientific and regulatory considerations for sponsors initiating biosimilar development programs.”
Source: FDA
Advertisement
Related to this article
As established gains in personalized and targeted therapy have enabled increasingly precise approaches to disease, novel technologies are expanding what is possible while creating new challenges for drug developers.
Exploring the emergence of agentic ecosystems in transforming data accessibility and ensuring reliable answers reach the people making decisions while there is still a choice to make.
A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.
Advertisement
Advertisement
Trending on PharmExec
1
The Bubble You Don’t Know You’re In: A Three-Part Series on The Medical Benefit Bubble
2
EMA Panel Backs Lilly’s Foundayo for Obesity and Type 2 Diabetes in Europe
3
FDA Approves Enspryng (Satralizumab) for Thyroid Eye Disease
4
Pharmaceutical Executive Daily: Gilead Enters $1.87 Billion Collaboration and License Agreement with Vir Biotechnology
5