In this week’s pharma news, US industry backs changes to reporting rules, EMA wants input on shortages caused by non-compliant plants, analyst forecasts biosimilar market growth and more…
US industry backs FDA plan to revise manufacturing reporting rules
Biomanufacturers have welcomed US FDA plans to revise when and how they must report changes to drug production processes.
The US FDA mooted revisions to chemistry, manufacturing, and controls (CMC) change-reporting rules in December, outlining a tiered system that has different requirements depending on the type of product.
At the time, the agency said the revisions are designed to take advances in manufacturing and processing technology into account and called for industry feedback on the idea.
Late last month the FDA published the comments it received. In general, the reaction was positive. Industry groups PhRMA and BIO welcomed efforts to the bring guidelines into line with advances in technology.
However, both groups had suggestions. BIO recommended that reporting rules for cell and gene therapies be “risk based,” while PhRMA raised concerns the revisions would require members to report data already included in GMP assessments.
Likewise, medical device and instrument firm BD pointed out that the provision requiring applicants ensure contractors comply with cGMP would be difficult to achieve for operations like packaging that are not subject to FDA inspections.
EMA calls for feedback on critical non-compliance cases
The EMA has asked how it should handle pharma firms that break manufacturers in the event that a ban would cause drug shortages.
The European regulator called for input on the issue in a consultation paper last week, explaining the aim is to develop a risk-based way of dealing with the supply of critical medicines in case of serious GMP non-compliance.
The Agency said several recent public health crises caused by supply shortages as a result of GMP compliance problem, adding that “Experience obtained has been analysed and a number of lessons learned have been identified.”
Analyst predicts global biosimilars market will top $28bn by 2020
The value of the global biosimilars market will increase from $5bn last year to $28bn by 2020 according to Mario DiPaola, a senior scientific director at Charles River Laboratories.
Writing in GEN last week DiPaola suggested the US biosimilar market will experience rapid growth, citing the seven approvals such products have been granted by the Food and Drug Administration (FDA) in the past two years.
He also forecast that, “healthcare savings in the US from biosimilars is projected to range from $24 billion up to $150 billion between 2018 and 2027.”
Also in the news
Novartis has accused Regeneron of infringing patents covering the process used to manufacturing its drugs Eylea and Zaltrap. Read the full report at FiercePharma.
An industry expert has urged drug companies to verify certificates of analysis (CoA) provided by API suppliers, and warned that failing to do so is a risk. See more at PharmTech.
The global contract research market will be worth $59.4bn by 2020 according to a new report.