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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®).
AbbVie announced that it has submitted applications to the FDA and EMA for a new indication for Skyrizi® (risankizumab) to treat moderately to severely active ulcerative colitis (UC). Skyrizi® is currently approved by both regulatory authorities to treat Crohn’s disease, psoriatic arthritis and psoriasis.
The November 2022 PBAC meeting has recommended the following biologics for PBS listing:
- Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatitis and uncontrolled severe asthma in patients aged 12 years and older.
- Merck’s pembrolizumab (Keytruda®) for the treatment of persistent, recurrent, or metastatic (Stage IVB) squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma of the cervix in patients whose tumours express PD-L1 combined positive score equal to or greater than 1. This is further to pre-existing listing for unresectable Stage III or Stage IV malignant melanoma, resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma, relapsed or refractory Hodgkin lymphoma, Stage IV (metastatic) non-small cell lung cancer, locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, relapsed or refractory primary mediastinal B-cell lymphoma, unresectable or metastatic deficient mismatch repair colorectal cancer and recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx.
- Pfizer’s pneumococcal polysaccharide conjugate vaccine, for the prevention of pneumococcal disease in individuals with an at-risk condition (≥ 18 years), non-Indigenous adults aged ≥ 70 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years. This was the first submission of the vaccine for the proposed vaccination populations.
- AbbVie’s risankizumab (Skyrizi®) (which was on the July 2022 PBAC meeting agenda but a decision was deferred to November 2022) to treat adults with severe Crohn’s disease, who have failed to achieve an adequate response, or are contraindicated, to prior systemic therapy, further to pre-existing listing for treatment for severe chronic plaque psoriasis
AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA. This is the first specific interleukin-23 inhibitor to be approved for Crohn’s disease.
AbbVie’s Skyrizi® (risankizumab): requesting General Schedule Authority Required listings for the treatment of severe Crohn’s disease and for complex refractory fistulising Crohn’s disease
AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) to the FDA for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.
Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL concentration formulation. Skyrizi® is indicated for plaque psoriasis in adults.
AbbVie announced it will present new data from a number of studies on its immunology products including Rinvoq® (upadacitinib), Skyrizi® (risankizumab) and Humira® (adalimumab) at the EULAR 2021 Virtual Congress of Rheumatology.
Product specific reports based on extracts from our BioBlast® database
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