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Tuesday, Oct 3, 2023

Amgen Drug Gets Second FDA Nod

Riabni can now be used to treat rheumatoid arthritis.

The U.S. Food and Drug Administration has approved Amgen Inc.’s Riabni in combination with chemotherapy drug methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor therapies.

Riabni, which is an antibody treatment and biosimilar to Rituxan, a Non-Hodgkin’s Lymphoma treatment, has already been approved for the treatment of rare disorders and cancer-related illnesses. 

“The approval of Riabni is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option,” Murdo Gordon, executive vice president of global commercial operations at Amgen, said in a statement.

Riabni was proven to be highly similar to Rituxan with no major differences in safety or efficacy.

Currently, Amgen has 11 biosimilars in its portfolio including potential treatments for cancer and chronic inflammatory diseases, some of which collectively account for billions of dollars in revenue for the Thousand Oaks biotech company. Five of those biosimilars are approved in the U.S. with three being approved in the European Union.

Riabni, which Amgen does not break out revenues for individually, is in a group of five other Amgen products that collectively accounted for $85 million in product sales in the first quarter of this year. That number marked an 18% increase year-over-year.

Antonio Pequeño IV
Antonio Pequeño IV
Antonio “Tony” Pequeño IV is a reporter covering health care, finance and law for the San Fernando Valley Business Journal. He specializes in reporting on some of the biggest names in the Valley’s biotechnology sector. In addition to his work with the Business Journal, Tony has reported with BuzzFeed News on the unsupervised use of Clearview AI, a controversial facial recognition technology. Tony, who also conducts freelance reporting, graduated from the USC’s Master of Science in Journalism program in 2021. He is in his fifth year as a journalist as of 2021.

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