FDA offers guidance on developing biosimilars

The Food and Drug Administration issued draft guidance that outline scientific and quality issues with developing drugs known as biosimilars. The guidance also addresses industry questions about the implementation of the Biologics Price Competition and Innovation Act, part of the Patient Protection and Affordable Care Act, which created an approval pathway for biosimilars, or follow-on biologics, which are generic versions of protein-based products. The FDA said it expects biosimilars to be “highly similar” to the biological product that received approval. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers,” said Dr. Janet Woodcock, director of the FDA’S Center for Drug Evaluation and Research, in a news release. The Generic Pharmaceutical Association said that competition from generic versions of biosimilars will help keep costs down for biologic medicines. “As proven with chemical prescription drugs, competition from generics will be the most important factor in holding down the cost of biologic medicines,” the GPHA said in a statement. Last month, the FDA submitted recommendations to Congress for the proposed Biosimilar and Interchangeable Products User Fee Program, which would raise money from drug manufacturers to help cover the costs of reviewing drugs in exchange for an efficient approval process.