Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems. According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evi...

Today, the US Food and Drug Administration (FDA) released its long-awaited guidance establishing a naming convention for biologicals, including related and biosimilar products. Background With the passage of the Affordable Care Act in 2010, the US created a new pathway for biosimilar products to come to market, similar to the pathway in place for generic drugs. This pathway allows companies to get biosimilars to market more quickly and cheaply by relying on clinical ...