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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: secukinumab


September 14, 2023

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:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

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®).

June 1, 2023

Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe hidradenitis suppurativa (HS) in adult patients who have had an inadequate response to conventional systemic HS therapy.  This is the first biologic treatment approved for HS in nearly a decade.  Novartis said a decision from the FDA for this indication is expected later this year.  

This approval follows the CHMP recommendation last month. 

April 26, 2023

Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the grant of marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa, an inflammatory skin disease.  The recommendation was based on results from two phase III trials which showed that patients who received Cosentyx® continued to improve beyond the primary endpoint analysis at week 16, with more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response at week 52.

Last year BioThera began phase III trials of BAT2306, biosimilar to Cosentyx®,  in patients with moderate to severe plaque psoriasis.


November 1, 2022

Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab (Cosentyx®) in patients with moderate to severe plaque psoriasis.


September 3, 2021

The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.

August 17, 2021

Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.


May 8, 2020

Results of the Novartis’ EXCEED study comparing adalimumab and secukinumab for the treatment of PSA (psoriatic arthritis) were released.  Researchers reported no statistically significant superiority between secukinumab and adalimumab as first-line treatment of psoriatic arthritis, but secukinumab was associated with a higher treatment retention rate than adalimumab.

BioBlast® extract From May 8, 2020 to September 14, 2023

BioBlast® Editor and Contributing Author

Naomi Pearce & Sian Hope

Naomi Pearce & Sian Hope

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Sian Hope, Lawyer

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