Roche’s Actemra Scores New Indication In Rare Autoimmune Disease

SSc-ILD Indication Comes With Biosimilar Competition On The Horizon

The blockbuster drug is expected to see overall sales declines in the next few years, and biosimilar competition could come as soon as 2023.

lung illustration
Roche received FDA approval for interstitial lung disease in the rare autoimmune disease systemic sclerosis • Source: Shutterstock

Roche Holding AG’s Actemra (tocilizumab) has received its latest in a string of US Food and Drug Administration approvals, for interstitial lung disease associated with systemic sclerosis (SSc-ILD), after the company managed to drill down and find a suitable subgroup out of two trials in SSc that failed overall. The approval comes at a time when Actemra is projected to see gradual sales declines and biosimilar competition over the next few years.

Roche said 5 March that it had received an FDA nod for Actemra as the first approved drug for slowing...

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