Celltrion's Avtozma wins FDA nod for pediatric COVID-19 use in US
In short
Celltrion said the US Food and Drug Administration granted an additional approval for its Avtozma (tocilizumab) intravenous formulation to treat COVID-19 in patients aged 2 and older. The approval widens the drug's COVID-19 indication from adults to children and adolescents. Avtozma is a biosimilar of Roche's Actemra; Celltrion said it will work to expand prescriptions in the US tocilizumab market.
Read the full story 2 min read
Celltrion said the US Food and Drug Administration granted an additional approval for the intravenous formulation of its autoimmune treatment Avtozma (tocilizumab) for COVID-19 in patients aged 2 and older, the company said on 7 October. The approval widens the drug's COVID-19 treatment population from adults to children and adolescents. Korean outlets reported the same announcement, several of them carrying it first at headline level. [ 1 , 2 , 3 , 4 , 5 , 6 ]
Avtozma is a biosimilar of Roche's Actemra, whose active ingredient is tocilizumab. It works by suppressing interleukin-6, a substance involved in triggering inflammation, thereby reducing excessive inflammatory responses. According to the reports, the product already holds US indications covering rheumatoid arthritis, giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis and COVID-19. [ 3 , 4 , 5 , 6 ]
Celltrion said it received FDA approval for Avtozma's subcutaneous and intravenous formulations in January last year, and later added a cytokine release syndrome indication for the IV form; the pediatric COVID-19 indication is the latest addition. Because the IV form is administered by medical staff in hospitals, the reports said prescription access at general hospitals and specialist institutions is important for market expansion, and Celltrion plans to broaden its prescribing base into paediatrics and emergency medicine. [ 4 , 5 ]
On market context, the documents cite the original drug's global sales of about 2.47 billion Swiss francs (about 3.7 trillion won) last year, and an IQVIA estimate that the US tocilizumab market was worth about $1.978bn (about 2.7692 trillion won) last year. [ 4 , 5 , 6 ]
Hankook Ilbo explained that COVID-19 treatments divide into antivirals, used mainly early in infection for patients at high risk of severe disease, and immunomodulators such as Avtozma, used for hospitalised patients whose inflammatory response has become severe. Apart from steroids, it said four immunomodulator ingredients are approved or authorised for COVID-19 in the US — tocilizumab, baricitinib, anakinra and vilobelimab — and that only tocilizumab and baricitinib are permitted for children. [ 6 ]
A Celltrion official said the company would strengthen communication with medical staff to expand prescriptions and its market share in the US, and another company comment cited by outlets said it would keep targeting the autoimmune disease treatment market. The reports of the approval are based on the company's announcement; the documents do not include a separate FDA statement. [ 3 , 4 , 5 , 6 ]
Why it matters
The approval adds a pediatric COVID-19 option in the US, where the documents say only two immunomodulator ingredients are cleared for children. For Celltrion it extends the US label of a product already approved there for several autoimmune conditions, in a US tocilizumab market that IQVIA estimated at about $1.98bn last year.
Key facts
- Celltrion said the FDA granted an additional approval for Avtozma intravenous formulation for COVID-19 in patients aged 2 and older. [ 1 , 2 , 3 , 4 , 5 , 6 ]
- The COVID-19 treatment population for Avtozma expands from adults to children and adolescents aged 2 and over. [ 4 , 5 , 6 ]
- Avtozma is a biosimilar of Roche's Actemra (tocilizumab) and works by inhibiting interleukin-6. [ 3 , 4 , 5 , 6 ]
- The product already holds US indications including rheumatoid arthritis, giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis and COVID-19. [ 4 , 5 , 6 ]
- Celltrion received FDA approval for Avtozma's subcutaneous and intravenous formulations in January last year and later added a cytokine release syndrome indication for the IV form. [ 4 , 5 ]
- The original drug Actemra recorded global sales of about 2.47 billion Swiss francs (about 3.7 trillion won) last year, and IQVIA estimated the US tocilizumab market at about $1.978bn (about 2.7692 trillion won). [ 4 , 5 , 6 ]
- The documents say that apart from steroids, four immunomodulator ingredients are approved or authorised for COVID-19 in the US — tocilizumab, baricitinib, anakinra and vilobelimab — of which only tocilizumab and baricitinib are allowed in children. [ 6 ]
Confirmed by several sources
- Celltrion said the FDA granted an additional approval for Avtozma IV formulation for COVID-19 treatment in patients aged 2 and older. [ 1 , 2 , 3 , 4 , 5 , 6 ]
- Avtozma is a tocilizumab biosimilar of Actemra that suppresses interleukin-6 signalling. [ 3 , 4 , 5 , 6 ]
- The COVID-19 indication now covers children and adolescents aged 2 and over, not only adults. [ 4 , 5 , 6 ]
Still unclear
- All details of the FDA decision are reported through Celltrion's announcement. The documents quote the company, not the FDA; no regulator statement or approval document is cited.
- When the pediatric COVID-19 indication becomes commercially available, or how widely it will be prescribed, is not stated. The documents give the company's intention to expand prescriptions but no launch date or volume target.
- The financial effect on Celltrion's US sales or market share is not quantified. The documents cite overall market size estimates but no forecast for the product.
What local media are saying
Timeline, local time
- Korea Economic Daily publishes its headline report on the FDA approval for Avtozma's pediatric COVID-19 indication. [ 1 ]
- Newsis publishes a headline report on the same approval. [ 2 ]
- Yonhap reports that Avtozma's IV formulation can be used for COVID-19 in patients aged 2 and older, citing Celltrion. [ 3 ]
- Asia Economy reports the additional approval and the US market context. [ 4 ]
- Seoul Economic Daily reports Celltrion's plan to expand prescriptions in the US tocilizumab market. [ 5 ]
- Hankook Ilbo reports the approval and explains the difference between antiviral and immunomodulator COVID-19 treatments. [ 6 ]