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.

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).