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).

On 29 August 2024, Drug Design, Development and Therapy published the results of a Mabpharm-sponsored phase 1 study regarding CMAB015, biosimilar to Novartis’ Cosentyx® (secukinumab).  The study demonstrated that Mabpharm’s CMAB015 showed equivalent pharmacokinetics and comparable safety and immunogenicity to Cosentyx®.

This news follows FDA approval of Celltrion’s global phase 3 trial of its secukinumab biosimilar, CT-P55, in August 2024.  Bio-Thera is also developing a biosimilar to Cosentyx®, BAT2306, and commenced a phase 3 clinical trial in November 2022, which is estimated to be completed in the second half of 2024.

On 16 August 2024, Bio-Thera announced that it has entered into a licensing and supply agreement with Pharmapark for BAT2306, biosimilar to Cosentyx® (secukinumab).  Under the agreement, Pharmapark will have exclusive rights to distribute and market BAT2306 in Russia and other CIS countries.  This expands upon existing agreements between the two companies in relation to biosimilar golimumab, BAT2506, and BAT2206, an ustekinumab biosimilar.

Bio-Thera commenced a phase 3 clinical trial of BAT2306 in November 2022, which is estimated to be completed in the second half of 2024.

Earlier this week Celltrion announced that it had received FDA approval for its global phase 3 clinical trial of its own Cosentyx® biosimilar, CT-P55. The FDA approved Novartis’ Cosentyx® in October 2023 for moderate to severe hidradenitis suppurativa.  Cosentyx® was also approved in June 2023 by EMA for the same indication.

On 14 August 2024, Celltrion received FDA approval for its global phase 3 clinical trial of CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).

Celltrion reports that global market sales for Cosentyx® reached US $4.98 billion in 2023, and that Novartis’ “material patent” to secukinumab will expire in January 2029 in the US and July 2030 in Europe.

The FDA approved Novartis’ Cosentyx® in October 2023 for moderate to severe hidradenitis suppurativa.  Cosentyx® was also approved in June 2023 by EMA for the same indication.

Bio-Thera is also developing a biosimilar to Cosentyx®, BAT2306, and commenced a phase 3 clinical trial in November 2022, which is estimated to be completed in the second half of 2024.

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional systemic adalimumab HS therapy.  

This comes months after Novartis announced, on 31 October 2023, that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe HS in adults.  

Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

On 27 October 2023 the National Institute for Health and Care Excellence (NICE) recommended Cosentyx® for moderate to severe HS.

Novartis announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending Cosentyx® (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults in England and Wales.   It will be recommended for patients with an inadequate response to conventional systemic HS therapy and where adalimumab is not suitable.

On 6 October 2023 the FDA approved Novartis’ new intravenous formulation of Cosentyx® for the treatment of adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Novartis announced that the FDA has approved its new intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

On 1 June 2023, Novartis announced that the European Commission approved Cosentyx® for a new indication to treat active moderate to severe hidradenitis suppurativa in adult patients who have had an inadequate response to conventional systemic HS therapy.