Federal regulators are trying to facilitate development Cheaper alternatives To the powerful medications that many Americans rely on to treat autoimmune diseases or cancer.
The Food and Drug Administration said on Wednesday that it had issued guidance to simplify studies of this drug Biological medicines And cut out unnecessary tests.
Biological medicines Made from living cells instead of mixing chemicals. It has led to major advances in the treatment of immune system disorders, eye diseases and some cancers since the late 1990s, but it is also very expensive.
For decades, biotech drugmakers have claimed that their drugs are too complex for competitors to imitate. That finally changed under President Barack Obama’s health reform in 2010, which ordered the Food and Drug Administration to create a system for approving “biosimilar drugs.” The term industrialization arose because scientists insisted that it would be impossible to produce exact copies of their biotech drugs.
The FDA’s trail, finally published in 2015, notes that drugmakers are conducting studies that show patients respond similarly to biosimilar versions when compared to the originals.
The latest proposal seeks to relax this standard, which the administration describes as an “unnecessary, resource-intensive requirement.”
Health Secretary Robert F. Kennedy Jr.: “The result will be more competition, lower prices, and faster access to life-saving medicines.”
The draft guidance is the first step in an extensive bureaucratic process. It amounts to a temporary set of recommendations for drug makers.
The FDA will receive public comments on its proposal for 60 days. Next, he must review and revise the document. The final guidance, expected within three to six months, will not be binding. It will serve as suggestions for drug makers working on biosimilars.
Competition from biosimilars has brought down prices somewhat for patients taking drugs such as the autoimmune disease treatment Humira. But this may not happen immediately. This can 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 also prompt drugmakers to lower the cost of their biologic drugs or offer larger rebates to keep their products on the formulary, experts say.
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Associated Press writer Ali Swenson contributed to this report.
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