In this week’s news, more Brexit drug approval worries, NHS plans biosimilar push, serialisation survey raises concerns and more…
Brexit may delay drug approvals
Brexit may delay the approval of several breakthrough cancer and depression drugs unless the UK can strike a regulatory deal with the EU.
Janssen – which has several drugs under EMA review – told the paper “For ongoing licence applications, where the decision phase has not been reached by the EMA, we would need to resubmit our application to the MHRA.”
This position was confirmed by the MHRA, which said while it hoped to use work already carried out by the EMA, there are no guarantees reviews would not be delayed.
NHS urges hospitals to switch patients to biosimilars
NHS England has urged Trusts to switch patients to biosimilar versions of branded drugs to save the service £150m a year.
The NHS made the comments last week, encouraging hospitals to adopt biosimilars to save money. It cited Humira (adalimumab) as an example explaining that if the 46,000 patients currently receiving the branded product were given a biosimilar instead it would save the service millions.
NHS England’s chief executive Simon Stevens said, “Adalimumab is the NHS’s biggest spend on a single drug and, as the NHS develops the long term plan, we want more clinicians to switch to use the best value biologics which will free up hundreds of millions of pounds to reinvest back into patient care.”
In total the NHS spends £17.4bn on medicines. NHS England said it wants to accelerate the uptake of biosimilars to try and save £300m a year by 2021.
Survey suggests drug firms not ready for next US serialisation deadline
Most drug packages sold in the US still do not have a readable barcode that is compliant with the Drug Supply Chain Security Act (DSCSA) according to a new survey.
The survey – which is based on an assessment of products that were being handled by three major wholesalers in May – found that only 20.7% of packages had a 2D data matrix barcode that included a National Drug Code, serial number, lot number and expiration date.
While this is an improvement on the 6.6% of products found to DSCA compliant marketing in a survey last year, the finding is a concern given that the next stage of the DSCSA is due to come into force in November.
Read more at RAPS.
US FDA wants to harmonize generics science
The US FDA wants to harmonize global scientific standards for generic drugs to better ensure product quality.
The regulatory announced the policy last week, explaining it had approached the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs.
One aim is to let drug firms run a single development programme that can be filed with regulators in multiple markets.
Commissioner Scott Gottlieb said the approach “would make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America.
“It would also make it easier for developers that would otherwise only seek generic drug approval in the US market to gain access to other markets.”
Also in the news
More details on how the UK drug industry is preparing for the UK’s withdrawal from the European Union. Read more at the Scientist.
Particle Sciences has confirmed it will expand capacity at its Pennsylvania site in response to customer demand. Read more here.