A row is brewing in the US over biosimilars. This time, it’s not about efficacy – it’s about what they should be called…
According to a survey of European prescribers of biologics and biosimilars, over 60% believe that if two products share an international non-proprietary name, they are approved for all of the same indications.
A letter sent to the FDA from a group of 11 medical associations and 23 individual US prescribers states the view that it is critical for follow-on products to have international non-proprietary names (INN) that are distinguishable from their reference products.
The group believes this will help warn physicians that each product could potentially cause different reactions among patients. It also believes that distinguishable names will help prevent inappropriate pooling of adverse events by clearly identifying which product a patient was prescribed.
However, last month, groups representing pharmacy, labour unions, health insurance plans and others voiced the opposite opinion – saying that requiring different INNs could lead to patient and prescriber confusion, increasing the possibility of medication errors and slowing the uptake of biosimilars.
Now a group of institutional investors has waded into the fight...
They have written to the boards of several major pharma and biotech companies, encouraging them to adopt a range of business principles to support the use of biosimilars. They believe that continued fighting over biosimilars will undermine shareholder value and limit any potential cost benefits the healthcare system can reap from the drugs.
According to the Wall Street Journal, the investor group manages around $430 billion in combined assets – a tidy sum even by big pharma standards!
The group thinks it would be a mistake to give biosimilars different names from the original products partly because there may be an inference that the newer product is less effective than the predecessor.
Furthermore, they specifically asked that pharma companies agree that all educational materials about biosimilars are fair and accurate and that all related lobbying expenses should be disclosed.
At the time of the Wall Street Journal report, only Amgen and Novartis had agreed to the proposed rules of engagement, Genentech had rejected the proposal and the others had yet to respond. It will be interesting to see what happens over the next few weeks.
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