On 3 October 2025, Celltrion announced that it has launched its intravenous formulation of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  Avtozma® IV is indicated for all reference indications, with the FDA approving an indication extension for the treatment of cytokine release syndrome (CRS) in August 2025.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025).  Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS listing at PBAC’s November 2025 meeting.

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

This marks the first tocilizumab biosimilar approved in Japan, with Celltrion planning to launch “quickly” to secure “first mover advantage”.

In May 2025, Avtozma® became the first approved tocilizumab biosimilar in Australia.  In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab.  Under the agreement, Bio-Thera will maintain responsibility for development, manufacture and supply of the biosimilar (to Roche’s RoActemra®), while STADA and its affiliates will have exclusive rights to commercialise the biosimilar in the EU, UK, Switzerland and selected other countries.

Bio-Thera and STADA have an existing agreement on similar terms in relation to the exclusive commercialisation of BAT2506 (biosimilar to J&J’s Simponi® (golimumab)), announced in May 2024.  In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA).

Bio-Thera’s tocilizumab biosimilar, BAT1806, was the subject of a commercialisation and licence agreement with Biogen entered in April 2021.  Biogen’s IV tocilizumab, Tofidence®, was approved in the EU in June 2024.

Other tocilizumab biosimilars currently approved in the EU are Fresenius Kabi’s Tyenne®, in both IV and SC forms, approved in November 2023 and Celltrion’s Avtozma®, approved in February 2025.

On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older.  With this approval, Avtozma® IV now aligns with all reference indications of Actemra® IV in the US.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS-listing at PBAC’s November 2025 meeting.

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:

• Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications;
• Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), for all reference indications; and
• Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for all reference indications.

Biosimilar aflibercept

Celltrion’s Eydenzelt® (approved March 2025) is the second aflibercept biosimilar to be considered by PBAC, following Sandoz’s aflibercept biosimilars Afqlir® and Enzeevu™, which were approved in May 2025 and considered by PBAC in July 2025.  The outcomes of the July 2025 meeting have not yet been published.  Beyond those of Sandoz and Celltrion, there are no other aflibercept biosimilars approved in Australia.

Biosimilar denosumab

In December 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Biosimilar tocilizumab

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered for PBS-listing.  In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence™ in June 2024.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®.  The results demonstrated comparable efficacy, pharmacokinetics, safety and immunogenicity between patient groups that maintained the reference product and those that switched to Avtozma®.

Celltrion launched Avtozma® in Korea in June 2025, following its approval in December 2024 for the same indications as Actemra®.  Just days earlier, Australia’s Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in the country.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.  Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea.  Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.

Just a few days earlier, the Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.  Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products:

• Injection concentrated vial: 80mg/4ml (444940), 200mg/10ml (444939) and 400mg/20ml (444943); and
• Solution for injection pre-filled pen: 162mg/0.9ml (444942), and 162mg/0.9ml (AVTPen Autoinjector) (444941).

Avtozma® has been approved for the same indications as Actemra® and is the first tocilizumab biosimilar to be approved in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab).  Product developer Bio-Thera Solutions will continue to manufacture the product.

Tofidence™ was the first US approved tocilizumab biosimilar (IV formulation, September 2023), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024) and Celltrion’s Avtozma® (IV and SC formulations, February 2025).