This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|July 22, 2016
EMA Accepts Pegfilgastim Biosimilar for Review
Author(s)Pharmaceutical Technology Editors
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.
Advertisement
On July 21, 2016 Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application (MAA) for its proposed biosimilar to pegfilgrastim. The drug was co-developed by Biocon and Mylan and is used to treat cancer patients. The drug minimizes the side effects of chemotherapy treatment, reducing the duration of neutropenia. According to Mylan, in addition to analytical, functional, and preclinical data, the application includes clinical data from pharmacokinetic/pharmacodynamic (PK/PD) studies completed earlier in 2016.
This comes after FDA sent a complete response letter to Sandoz for Neulasta, its biosimilar candidate to pegfilgrastim. Novartis released a statement in its Q2 report saying the company is working with FDA to address remaining questions.
Advertisement
Related to this article
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
Karthik Iyer, Eli Lilly, detailed an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
AI can turn medical device risk management into a continuous signal.
Advertisement
Advertisement