Six months can make all the difference for a company that wants to put a biosimilar on the market. That’s the main issue the Solicitor General wants the Supreme Court to look at in a recommendation that the high court settle a dispute between the makers of biosimilars, and the makers of the more expensive brand biologics that they would compete against, according to STAT Plus. Biosimilars have proven to be a conundrum for the FDA. The market welcomes generics, which are exact replicas of the brand name drug, but a lot cheaper. Biosimilars are not exact replicas, but come pretty close. Hence, the hesitation to approve.
The FDA so far has approved only four biosimilars, but their cost-savings potential are evident. As STAT Plus reports, QuintilesIMS Institute for Healthcare Informatics estimates that those four biosimilars can save the health care system between $27 billion and $58 billion by 2021.
In addition to doing away with the six-month wait, which is contained in the Biologics Price Competition and Innovation Act, the Solicitor General’s brief, filed Wednesday, argues that “biosimilar manufacturers should not be required to wait until the FDA approves its drug before giving notice to the brand-name company about its marketing plans,” according to STAT Plus. This contradicts a federal appeals court ruling given last summer.
The Solicitor General’s brief also argues that brand-name manufactures should not be allowed to get injunctions to prevent biosimilar companies from proceeding with their marketing plans if they do not give a six-month notice.
Source: STAT Plus (registration required)