Gedeon Richter gains FDA nod for biosimilar products

Hungary’s largest drugmaker Gedeon Richter (RICHT: HB) has received approval for its biosimilar products for the first time following a multi-agency inspection conducted by the US Food and Drug Administration (FDA).

During the approval process, the FDA conducted a total of nine on-site inspections: at five clinical trial sites, three support laboratories – including Richter's pharmacokinetic laboratory – and at the Debrecen site, where the agency inspected the biotechnological active ingredient production, sterile preparation plant, development activities and support functions over a two-week period.

The company noted that, in the Central and Eastern European region, there are only a few sterile manufacturing capacities other than Richter that can meet US regulatory requirements, and in terms of biotechnology development and manufacturing capacities, only Poland has an approved manufacturing site similar to Richter.