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House Oversight and Reform Committee Chairman Henry Waxman (D-Calif.) has taken an interest in the debate over how
the FDA can approve follow-on biologics, holding a hearing on
the issue featuring scientists from the pharmaceutical industry.
As part of a legal settlement, Novartis will assist Bayer Schering Pharma in obtaining FDA validation of Bayer’s outsourced European Betaseron manufacturing facility, Bayer told DGR March 27. The facility is operated by Boehringer Ingelheim.
As the debate over how the FDA should approve follow-on biologics continues, lawmakers acknowledged more work is needed to satisfy certain patient safety and interchangeability concerns raised by the pharmaceutical industry.
Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
A pathway for creating and marketing generic biologics could help health plan sponsors and patients save $71 billion over the next 10 years, according to an Express Scripts report.
As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.
The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.
Reintroduction of key legislation presented late last year that would establish a clear and scientifically sound pathway for the approval of follow-on biologics would save the federal government about $14 billion in Medicare costs over the next decade, according to a new report by the Pharmaceutical Care Management Association (PCMA).
A European generic trade group expressed doubts over the validity of a new briefing report released by the International Alliance of Patients’ Organizations (IAPO), saying the report fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.
Generic drugmakers successfully capitalizing on the multi-billion dollar antihypertensive market are driving large brand producers to redirect their R&D strategies toward a more profitable market, a new Datamonitor report says.