Monday 09 March 2026 – 11:55 AM
Bloomberg News reported, citing an official in Food and Drug Administration In US and internal documents, the agency intends to ease testing requirements imposed on companies developing biosimilar drugs.
The US Food and Drug Administration plans to ease testing requirements for biosimilar drugs
The Food and Drug Administration is expected to issue new draft guidance as early as Monday, aimed at reducing the need for some studies used to prove that biosimilar drugs are identical to the original branded treatments on which they are based, according to Bloomberg, citing an agency official and a document it has seen.
Significant reduction in development costs
The report stated that the proposed changes may contribute to reducing the cost of developing similar biopharmaceuticals by about $20 million. This trend comes within broader efforts by the US Food and Drug Administration to facilitate companies obtaining regulatory approvals for these drugs in the United States.
Officials believe that expanding the use of biosimilar drugs may be an effective way to help reduce drug prices in the American market.
Different nature from generic medicines
Biosimilars differ from traditional generic drugs, in that the latter are low-cost identical versions of chemical drugs that are easy to manufacture, such as pills. As for biological medicines, they are made from living cells, which makes it difficult to produce a completely identical copy of them, so they are described as bioidentical medicines.
