March 9 (Reuters) – The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex biologic medicines, aiming to lower the cost of treatments for diseases such as cancer and autoimmune disorders.
Biologic medicines, made from living cells, are among the most expensive drugs on the market. While they make up about 5% of prescriptions, they account for 51% of drug spending, the U.S. Food and Drug Administration said.
The agency, in the draft guidance, recommended streamlining certain studies testing how the body interacts with a drug when there is enough scientific evidence. It said the change could reduce pharmacokinetic study costs for biosimilar developers by up to 50%, or about $20 million.
“Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans,” FDA Commissioner Marty Makary said in a statement.
Unlike cheap generic versions of simpler pills, medicines made from living cells cannot be exactly copied and are therefore known as biosimilars. The FDA said it has approved 82 biosimilars for use in the U.S.
According to the draft guidance, companies may, in some cases, use clinical data based on a comparable version of the original drug approved outside the United States without running an additional three-way study involving the proposed biosimilar, the U.S.-licensed reference drug and the foreign comparator.
The agency also said it was withdrawing a 2015 guidance on how to show that a biosimilar matches its reference medicine, saying the document no longer reflects its current thinking after years of reviewing such applications.
The move follows another draft guidance announced in October that aimed at reducing certain studies comparing how well biosimilars work, which the FDA said could take one to three years and cost about $24 million.
(Reporting by Sahil Pandey in Bengaluru; Editing by Nivedita Bhattacharjee and Shilpi Majumdar)
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