19 October 2023

Toci biosimilars approved overseas

Biosimilars FDA

Tocilizumab biosimilars from Biogen and Fresenius Kabi have been approved in the US and Europe respectively.

The FDA has approved Biogen’s tocilizumab biosimilar Tofidence (BIIB800), the first tocilizumab biosimilar to be approved in the US.

The intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Approval was based on analytical and non-clinical data, as well as the results of two clinical trials: a phase I study in healthy volunteers to determine pharmacokinetics, safety and immunogenicity; and a phase III double-blind RCT comparing the biosimilar with the reference product in patients with RA inadequately controlled by methotrexate.

“The approval of Tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, global head of biosimilars at Biogen in a company statement.

“With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics,” he said.

The company has not yet stated when it will be available.

Meanwhile, Fresenius Kabi has had its tocilizumab biosimilar Tyenne (MSB11456) approved in Europe.

Available in injectable and IV forms, the drug is approved for conditions including rheumatoid arthritis, giant cell arteritis, polyarticular JIA and systemic JIA, as well as cytokine release syndrome and covid.

“We are proud to be the first company to receive the marketing authorisation for a tocilizumab biosimilar from the European Commission,” said Fresenius Kabi CEO Pierluigi Antonelli in a company statement.

“Being on the cutting edge of proposing an affordable, high-quality, and safe tocilizumab treatment option to health care providers and patients living with autoimmune diseases is an exciting step in our mission to provide access to alternative treatment options,” he said.

Fresenius Kabi has also submitted an application for the biosimilar to the FDA.

Biogen and Fresenius Kabi in Australia told Rheumatology Republic they were unable to comment on any potential applications to the TGA for their respective tocilizumab biosimilars.

After tocilizumab supply issues in 2021 resulted in global shortages, the development of biosimilars was welcomed by rheumatologists.