The US Food and Drug Administration is seeking to facilitate the development of cheaper alternatives to the biologic drugs that many Americans rely on to treat autoimmune diseases or cancer.
The authority announced yesterday, Wednesday, that it had issued directives aimed at simplifying studies of vital medicines and reducing unnecessary tests.
For decades, biopharmaceutical companies have argued that their drugs are too complex to be imitated by competitors.
But this situation finally changed in light of the health care reforms approved by former US President Barack Obama in 2010, which obligated the US Food and Drug Administration to establish a system for approving what are known as “biosimilars” (biosimilars).
The term “biosimilars” arose in this field because scientists emphasized the impossibility of producing exact copies of the original biologics.
US Secretary of Health Robert F. “The result will be more competition, lower prices, and accelerated access to life-saving medicines,” Kennedy Jr. said.
Experts said that over time, similar biological medicines could prompt companies producing the original medicines to lower the prices of their biological medicines or offer greater discounts in order to maintain their products’ position on the approved drug lists.