On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.

With the new indication, Amgen’s Riabni® is now approved for all indications of Genentech/Biogen’s Rituxan®, while Celltrion’s Truxima® is approved for all of Rituxan®’s non-paediatric indications.  Pfizer’s Ruxience® is the only biosimilar without full adult coverage, missing both chronic lymphocytic leukemia and rheumatoid arthritis.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997.  Truxima®, Riabni® and Ruxience® are currently the only three rituximab biosimilars approved in the US market, with Dr Reddy’s rituximab biosimilar being knocked back by the FDA in April 2024.

On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for “frequently relapsing or steroid-dependent nephrotic syndrome” in childhood (IV injection, 100mg and 500mg) that has not yet become intractable.

Rituxan® was approved in Japan in November 2024 for chronic idiopathic thrombocytopenic purpura (ITP) in children. Prior to this, Rituxan® had only been approved in Japan for chronic ITP in adults.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for chronic idiopathic thrombocytopenic purpura (ITP) in children (IV injection, 100mg and 500mg).  Rituxan® was previously approved in Japan for chronic ITP in adults only.

Rituximab is not currently approved in the US or EU for chronic ITP.

Genentech and Biogen collaborate on Rituxan® in the United States, and Roche markets the drug as MabThera® in the rest of the world, except Japan, where Rituxan® is co-marketed by Chugai and Zenyaku.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales.  Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab.  Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023).  It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and  Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US.  Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November.  Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023),  CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

Shanghai Henlius Biotech has revealed its financial results for the first half of 2024, reporting revenue of RMB2.7461 billion (an increase of 9.8% YOY) and a record net profit of RMB2.7461 million (an increase of 61% YOY).

Henlius attributes its profits to increasing commercial sales of its core products; namely, its trastuzumab biosimilar HANQUYOU/HLX02 (known as Hercessi^TM in the US and Zercepac® in Europe) and HANSIZHUANG (serplulimab), its treatment for small-cell lung cancer, which has been launched in China, Indonesia, Cambodia and Thailand.  Henlius reports that its MAA for HANSIZHUANG has been validated by the European Medicines Agency (EMA) and is expected to be approved in 2024.  Henlius plans to submit a BLA for the product in the US in early 2025.

Other milestones noted by Henlius include the approval of HANLIKANG (biosimilar rituximab) in Peru and acceptance of its European MAA for HLX14 (biosimilar denosumab) in May 2024.  Henlius plans to submit marketing applications for HLX14 in the US, and for HLX11 (biosimilar pertuzumab) in the US and China, in the second half of 2024.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 and HLX11 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

On 1 August 2024, Navlin Daily reported that Brazil’s National Commission for the Incorporation of Technologies into the Unified Health System (CONITEC) recommended against incorporating rituximab monotherapy in Brazil’s national health system for treating asymptomatic follicular lymphoma (FL).

Rituximab is marketed in Brazil by Roche under the brand name MabThera.  Available biosimilars include Pfizer’s Ruxience® and Celltrion’s Truxima®.

Therapeutic options available in Brazil’s Unified Health System (SUS) for FL vary depending on the tumour’s classification.  CONITEC’s latest assessment regards initial phase classifications (stages I and II) and one advanced phase (stage IIIA).

CONITEC’s view is that scientific evidence regarding the benefit of rituximab is limited and that there is no consensus among experts in the field regarding the treatment of the disease in the asymptomatic phase.  On this basis, CONITEC recommended against incorporating in the SUS rituximab as monotherapy for patients with asymptomatic FL, regardless of initial stage.

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.   

Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202).  All are indicated for plaque psoriasis (adult and paediatric), psoriatic arthritis and Crohn’s disease, with Eksunbi and Fymskina additionally indicated for ulcerative colitis.  

These CHMP positive opinions follow earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024.  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma® (CT-P47, ustekinumab).  Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted. 

Positive CHMP opinions were also adopted at the July 2024 meeting for Dr Reddy’s Ituxredi™, biosimilar to Genentech/Biogen’s Rituxan® (rituximab), Midas Pharma’s Ranibizumab Midas, biosimilar to Genentech’s Lucentis® (ranibizumab) and Prestige Biopharma’s Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab). 

In addition, CHMP adopted positive opinions for two innovator biologics, extended indications for five and issued a negative opinion for one, as reported here. 

Dr Reddy’s announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for biosimilar rituximab (DRL_RI), biosimilar to Genentech/Biogen’s Rituxan®.   The CRL is said to relate to the ongoing resolution of results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”. 

In April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab. 

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020),  Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Fresenius Kabi in respect of Dr Reddy’s proposed DRL_RI (rituximab), biosimilar to Genentech’s/Biogen’s Rituxan®.  The terms of the settlement between the parties have not been publicly disclosed.

The proceeding was commenced on 17 November 2023, following Dr Reddy’s submission of its aBLA to the FDA seeking approval for DRL_RI.  DRL_RI was to be commercialised by Fresenius in the US and by Dr Reddy’s in other jurisdictions.

Rituximab is an old molecule and was one of the first mAbs to become “biosimilar”, with the first rituximab approval in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020),  Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).