In this week’s news, Covid-19 impacting US biosimilar reviews, US bids to streamline EO sterilization rules for device CDMOs and more…
US FDA missing biosimilar review targets due to pandemic says report
The CDER says increased demand and logistical challenges during the latter part of 2020 meant that it did not meet biosimilar review targets.
The CDER shared details this week, explaining that although the agency met most of its user fee goals, its performance in moving original biosimilar applications fell short.
According to the report, 100% of applications were handled on time under the BSUFA – the Biosimilar User Fee Act – during Q3 last year. However, for applications containing manufacturing supplements this fell to 95% and 94% in the next two quarters.
Similarly, in the last quarter of 2020 only 75% of original biosimilar product applications were acted on by target date. And in the first quarter of 221, this fell to just 67%.
MHRA: UK drug firms shipping to NI have flexibility for batch release
The UK MHRA has issued guidance on the importation of medicines into Northern Ireland before 31 December.
The guidance – issued in response to a European Commission notice affording markets that traditionally rely on UK drug exports more time to adapt to post-Brexit changes – states UK firms with drugs approved before January 31 have flexibility regarding batch release.
According to the MHRA, “The justifiable reason for using the flexibilities exists where each batch is released by a QP on an EU site, or a UK site demonstrating equivalent standards; and that the establishment is supervised. This is to ensure continued supply to Northern Ireland.”
US FDA aims to help device CDMOs reduce ethylene oxide emissions
The US FDA has tweaked rules for the sterilization of medical devices using ethylene oxide (EO) to aid contractors and manufacturers.
According to Packaging Digest the revisions – which are part of a wider EO master file pilot programme – are designed to streamline the regulatory process for the company holding the EO Master File and for any device CDMOs involved.
Also in the news
Science covered concerns about the safety of AstraZeneca’s Covid-19 vaccine.
RAPS reported the launch of a US FDA dashboard for drugs granted emergency use authorization (EUA) to treat COVID-19.
Reuters looked at EU Covid-19 vaccine supply efforts. Production delays at AstraZeneca may be offset by faster than planned production at Pfizer.
Nature looked at the history of orphan drugs in Japan. The number of developers seeking the designation have increased markedly in the 25 years since the pathway was introduced.
In related news, RAPS looked at growing use of the orphan pathways in the US and Europe.
Labiotech covered trends in technology transfer in the CDMO space.
Some developments of note in the contracting sector:
ANI Pharmaceuticals will pay $210 million for generics firm Novitium Pharma in a deal design to boost its drug portfolio and CDMO business. See press release.
Maravai has announced plans to expand its contract manufacturing business – called TriLink Biotechologies – with the addition of plasmid DNA production services. See more at Contract Pharma.
PhaseBio Pharmaceuticals has hired BioVectra to make bentracimab a monoclonal antibody fragment intended to reverse of the antiplatelet effects of stroke prevention drug Brilinta (ticagrelor). See more at Genetic Engineering and Biotechnology News.
Wuxi Vaccine says construction of the plant it is building in Dundalk, Ireland is weather-tight and on track to be operational in 2022. See press release.
In related news, Reuters reports Pfizer will stop making biosimilar drugs in China and sell its Hangzhou manufacturing facility to Wuxi Biologics, a sister company of Wuxi Vaccines.