Federal health officials push effort to spur cheaper biotech drugs
Federal regulators are trying to make it easier to develop cheaper alternatives to the powerful drugs that many Americans rely on to treat autoimmune diseases or cancers.
The Food and Drug Administration said Wednesday it has issued guidelines aimed at simplifying studies of biologic drugs and eliminating unnecessary testing.
Biologic drugs are made from living cells rather than a mixture of chemicals. They have enabled major advances in the treatment of immune system disorders, eye diseases and some cancers since the late 1990s, but they are also very expensive.
For decades, biotech drugmakers have argued that their drugs are too complex for competitors to copy. This finally changed with President Barack Obama’s healthcare reform in 2010, which directed the FDA to create a system for approving “biosimilar drugs.” The industrial term emerged because scientists insisted that it would be impossible to produce exact copies of their biotechnology drugs.
The FDA’s approach, finally released in 2015, suggests that drugmakers conduct studies showing that patients respond similarly to biosimilar versions compared to the originals.
The latest proposal aims to relax that standard, which the administration calls an “unnecessary and resource-intensive requirement.”
“The result will be more competition, lower prices and faster access to life-saving medicines,” State Health Secretary Robert F. Kennedy Jr. said.
The draft guidelines constitute the first step in a vast bureaucratic process. This is an interim set of recommendations for drug manufacturers.
The FDA will receive public comments on its proposal for 60 days. After that, he must review and revise the document. The final guidelines, expected in three to six months, will not be binding. It will serve as suggestions for drugmakers working on biosimilars.
Competition from biosimilars has brought some price reduction to patients taking drugs such as autoimmune disease treatment Humira. But it may not happen immediately. This may depend on insurance coverage and whether the biosimilar is added to a pharmacy benefit manager’s list of covered medications.
Experts say that over time, biosimilars may also cause drugmakers to lower the cost of their biologic drugs or offer deeper discounts to keep their product on a list.
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Associated Press writer Ali Swenson contributed to this report.
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