With the potential to cure devastating illnesses in a single dose, drugmakers say they justify treatment prices well above $1m per patient
Bengaluru — Eleven drugmakers led by Pfizer and Novartis have set aside a combined $2bn to invest in gene therapy manufacturing since 2018, according to a Reuters analysis, in a drive to better control production of the world's priciest medicines.
Drugmakers say building their own manufacturing plants is a response to rising costs and delays associated with relying on third-party contract manufacturers, which are also expanding to capitalise on demand. There are currently several hundred under development by about 30 drugmakers for conditions from haemophilia to Duchenne muscular dystrophy and sickle cell anaemia.
They follow Biomarin Pharmaceutical, developer of a gene therapy for haemophilia, which constructed one of the industry's largest manufacturing facilities in 2017.The US's Food and Drug Administration is keeping a close eye on standards. This comes amid the agency's disclosure in August that it is investigating alleged data manipulation by former executives at Novartis's AveXis unit.
But the scandal has highlighted the importance of having a consistent manufacturing process for gene therapies, industry executives say.
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