In this week’s news, shortage of API suppliers a threat, risk of post Brexit shortages reduced, China’s CMO shortfall and more…
Smaller API CMO pool a threat, but also an opportunity says EMA chief
Over reliance on too few contract API suppliers can cause drug shortages according to EMA executive director Guido Rasi, who has called on pharma to rebuild ingredient capacity.
Rasi – whose comments were reported by Pharmaceutical Technology last week – was part of a panel that discussed the impact globalization has had on the pharmaceutical industry.
He told attendees that API sector consolidation– driven in part by pricing pressure – has narrowed the talent pool and led to reliance on too few API suppliers.
“For high-volume blockbuster drugs, there are fewer choices of a manufacturing site… this risks devastating consequences if there is a disruption to supply,” he said.
However, Rasi suggested there may be an upside to consolidation, arguing that it could allow higher capacity and homogenous quality.
He added that regulators need to adapt resources to help underpin supply chain resilience, providing faster responses and new ways to supervise CMOs.
Brexit could still hit drug supplies but progress being made says EMA
The EMA says the number of drugs likely to be in short supply after the UK withdraws from the EU has decreased.
The agency announced that “the number of medicines at risk of shortages continues to decrease because more companies take the necessary steps to ensure that their medicines can remain on the market.
“Work is still ongoing with national competent authorities to verify availability and identify alternatives at national level.”
It also cited certain measures it has put in place – notably its suggestion in February of possible exemptions to the rules for batch testing – had improved the situation.
But, while there has been progress, post Brexit shortages in the UK and EU are still a possibility according to the EMA.
It wrote “Despite the proactive approach by the European medicines regulatory network, there is still a high risk of supply issues with some medicines if the UK were to leave the EU without a withdrawal
China lacks CDMO capacity
There are not enough CDMOs in China according to Wuxi Biologics CEO, Chris Chen Zhisheng.
The executive told the South China Morning Post about the lack of capacity last week, suggesting that a 30-fold increase would be required to service current projects and future demand.
He told the paper, “China’s contract outsourcing market is only tiny partly because many drug developers insist on in-house manufacturing, which they consider part of their core competencies.”
However, he predicted recent Government efforts to force drug firms to cut prices will increase demand for third party manufacturing capacity.
Read the full article here.
Latest mAb failure may prompt Alzheimer’s R&D rethink say experts
The drug – a monoclonal antibody – targets the sticky deposits of amyloid proteins, so called plaques, present in the brains of patients suffering from Alzheimer’s.
The theory is that the disease is the result of the gradual build of these plaques and that removing them will halt progression.
But Aducanumab’s failure could force industry to rethink its approach and abandon the amyloid plaque theory according to some observers.
Alzheimer's and amyloid, in light of today's Biogen/Eisai announcement: for God's sake, try something else. The classic amyloid hypothesis has never delivered, not once, not ever.https://t.co/k2FuS7SaC2
— Derek Lowe (@Dereklowe) March 21, 2019
US FDA lets some firms sell contaminated blood pressure pills during shortage
The US FDA will temporarily allow some firms to sell blood pressure meds that contain a probable cancer-causing impurity while shortages continue.
The regulator announced the decision last Wednesday, explaining to ensure patients have access to losartan it will allow some firms to sell batches of the drug that contain the impurity NMBA on a temporary bases.
NMBA – or N-Nitroso-N-methyl-4-aminobutyric acid – is a potential cancer causing chemical that has been detected in APIs used to make losartan.
The FDA has ordered the recall of multiple batches of losartan and is working with manufacturers and API suppliers to try identify the source of the NMBA. As a result, suppliers are limited.
Also in the news
Industry Europe looked at the increased use of ultra-low temperature reactions during API and drug production. Such chemistries are a particular challenge for manufacturing technologies according to the author.
The FDA has issued warning about certain implantable cardiac monitoring devices over concerns they may be vulnerable to hackers. Read more here.