Federal health officials push effort to spur cheaper biotech drugs
Federal regulators try to make development easier cheaper alternatives to powerful drugs that many Americans use to treat autoimmune diseases or cancers.
The Food and Drug Administration said Wednesday it had issued guidance to simplify the studies. biological drugs and cut out unnecessary testing.
biological drugs It is made from living cells rather than mixing chemicals. These have led to major advances in the treatment of immune system disorders, eye diseases and some cancers since the late 1990s, but they are also very costly.
For decades, biotech drugmakers have argued that their drugs are too complex to be copied by competitors. That finally changed with President Barack Obama’s 2010 healthcare overhaul, which ordered the FDA to create a system for approving “biosimilar drugs.” The term industry arose because scientists insisted that it was impossible to produce exact copies of biotechnological drugs.
The FDA’s guidance, finally published in 2015, suggests that drugmakers have conducted studies showing that patients respond similarly to biosimilar versions compared to the originals.
The latest proposal aims to ease this standard, which the administration calls an “unnecessarily resource-intensive requirement.”
“The result will be greater competition, lower prices and faster access to life-saving medicines,” said Surgeon General Robert F. Kennedy Jr..
The draft guide is the first step in a comprehensive bureaucratic process. This amounts to a tentative set of recommendations for drug manufacturers.
FDA will seek public comment on its proposal for 60 days. After that, he/she should review and revise the document. The final guidance, which is expected to last three to six months, will not be binding. It will be a recommendation for pharmaceutical manufacturers working on biosimilars.
Biosimilar competition has brought some price reductions to patients taking drugs like the autoimmune disease treatment Humira. However, this may not happen immediately. This may depend on insurance coverage and whether the biosimilar has been added to the pharmacy benefit manager’s list of covered drugs.
Over time, biosimilars could encourage drugmakers to lower the cost of their biologic drugs or offer bigger discounts to keep their products on formulary, experts say.
Associated Press writer Ali Swenson contributed to this report.
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