THE national biotechnology body says recent US health reforms will ‘change the game’ for Australian biologics companies, with patent life extension for products including vaccines and allergenics.
AusBiotech CEO Dr Anna Lavelle, says the US health reforms change the Hatch-Waxman Act, increasing biologic patent life extensions from five to 12 years.
“The game is changing and it means that some biologic technologies that may have been put in the drawer before will now have a more reasonable return on investment, factoring in longer times before generics get to the market,” she says.
“It could be significant because with the big pharma companies looking at their project pipelines, about 25 per cent of those in the pipeline are biologic and by 2025 it could grow to about 50 per cent.
“Before they had the two mistresses of speed and getting it right, but this takes the weight off significantly and that’s good news.”
She says while biotech companies will benefit because they will have more time to perfect their products, generics companies are looking at the situation ‘philosophically’.
For Brisbane-based Alchemia, the patent life extension will mean delays for some of its biologics products under development, dealing with the delivery of ‘super generics’ that can only be released once patent exclusivity expires.
CEO Dr Pete Smith (pictured), says the US health reform is good overall for the biotech sector but it’s ‘not a great sea change’, as increased access to pharmaceuticals will be partially offset by a push for affordability.
“Longer patent lives mean we will have to wait longer before we get to delivery on the market. The matter is that we’ll see patients able to receive drugs more widely, but there will be a push for affordability so the net value for pharmaceuticals will be quite neutral,” he says.
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