The TGA website has been updated to include a number of new originator applications for the months of July and August 2024.

The following expanded indications are being sought for MSD’s Keytruda® and BMS’s Opdivo®:

• BMS’s Opdivo® (nivolumab) for the treatment of patients with unresectable or metastatic colorectal cancer;
• MSD’s Keytruda® (pembrolizumab) for the treatment of recurrent locally advanced or metastatic Merkel cell carcinoma; and
• MSD’s Keytruda® (rch) in 100mg/4 mL concentrated injection vial for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma.

As previously reported, the agenda for the September PBAC Intracycle Meeting includes an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to advise on next steps to seek broader stakeholder input”.  This agenda item is a multi-brand initiative that likely stems from efforts by MSD and BMS to secure expanded listings for Keytruda® (pembrolizumab) and Opdivo® (nivolumab) respectively.

Other applications currently under evaluation by the TGA are:

• BMS’s Yervoy® (ipilimumab) in combination with nivolumab for the treatment of patients with unresectable or metastatic colorectal cancer;
• BeiGene’s Tevimbra® (tislelizumab) for the treatment of recurrent or metastatic nasopharyngeal carcinoma;
• Amgen’s Imdelltra® (tarlatamab) for the treatment of adult patients with advanced small cell lung cancer;
• Novartis’ Ilaris® (canakinumab) for the treatment of several autoinflammatory Periodic Fever Syndromes; and
• Accelagen’s Briumvi® (ublituximab) for the treatment of relapsing forms of multiple sclerosis.

On 12 September 2024, Ono Pharmaceutical and Bristol-Myers Squibb announced they submitted a supplemental application in Japan for Ono’s Opdivo® (nivolumab) and BMS’s Yervoy® (ipilimumab) in combination therapy, to expand use to unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer.

This follows an August 2024 application in Japan for the same combination for unresectable hepatocellular carcinoma.

New Zealand’s government drug funding agency Pharmac has announced that BMS’ Opdivo® (nivolumab) will be fully funded for eligible kidney patients from 1 November 2024.

As previously reported, New Zealand has recently increased funding for cancer drugs, including Keytruda® (pembrolizumab).  The Cancer Society has welcomed this move but expressed doubt that New Zealand’s health system is currently able to deliver these drugs to patients.

On 1 September 2024, the PBS published its agenda for the September PBAC Intracycle Meeting, which will include an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to advise on next steps to seek broader stakeholder input”.

This agenda item is a multi-brand initiative that likely stems from efforts by MSD and BMS to secure expanded listings for Keytruda® (pembrolizumab) and Opdivo® (nivolumab) respectively.  This would allow wider access to indications with existing or future TGA approval for their checkpoint inhibitor therapies.  These submissions were deferred by PBAC in its December 2023 meeting.

In August 2024, BMS’ Opdivo® joined Keytruda® in being listed on the PBS for treating resectable non-small cell lung cancer.

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate-9DW trial.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of 21 April 2025.

We have previously reported the submission of an equivalent application by Ono Pharmaceutical and BMS for this combination in Japan.

On 12 August 2024, Xbrane reported that it has commenced processes to out-license Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol).  The out-licensing process is to ensure “financing until envisioned positive operational cash-flow in Q2 2025”, including following the termination of Xbrane’s commercialisation and licensing agreement with Biogen earlier this month in relation to XB003.

Xbrane reports that initial discussions have been held with interested parties regarding the out-licensing of XB003 and it expects a licence agreement to be signed by the end of October 2024 at the latest.  The out-licensing of Xcimzane™ is reportedly proving more difficult given likely high costs for phase 1 and 3 trials of the biosimilar.  Xbrane says that it is seeking a streamlined clinical development plan for Xcimzane™ from regulatory authorities in Europe and the US.

On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA.  Xbrane states it is working toward re-submitting the BLA for its ranibizumab biosmialr, Ximluci®, to FDA in Q4 2024.  Xbrane and STADA announced the continental European launch of Ximluci® in April 2023.

Ono Pharmaceutical and Bristol-Myers Squibb have announced a supplemental application in Japan for Ono’s Opdivo® and BMS’s Yervoy® in combination therapy, to expand its approved use to the treatment of unresectable hepatocellular carcinoma (HCC).

Ono’s 2011 grant to BMS of commercialisation rights for Opdivo® excluded Japan, South Korea and Taiwan, where Ono retained all rights.  In July 2014, Ono and BMS agreed to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.

Previous approvals for combination therapies for HCC include Tuoyi® (toripalimab) with bevacizumab (July 2024) and Tyvyt® (sintilimab) with Byvasda® (bevacizumab) (June 2021), both in China.

The combination of Opdivo® and Yervoy® is also the subject of an application by BMS in Australia in respect of unresectable malignant mesothelioma

On 6 August 2024, Amgen announced its financial results for Q2/2024, reporting total revenues increased 20% to US$8.4 billion compared with Q2/2023.  Twelve of its products delivered at least double-digit sales growth in the quarter, including Prolia® (denosumab), Repatha® (evolocumab), Evenity® (romosozumab-aqqg), Tezspire® (tezepelumab-ekko) and Blincyto® (blinatumomab).

Biosimilar highlights for the quarter include the FDA approval of Amgen’s Bkemv® as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab) in May 2024, initiation of a Ph 3 study in May 2024 to compare efficacy and safety of Amgen’s ABP 234 with Keytruda® (pembrolizumab), and the enrolment of patients in a study evaluating pharmacokinetic similarity of Amgen’s ABP 206 compared with BMS’ Opdivo® (nivolumab).

On 1 August 2024, Pharmacy Daily reported that Bristol Myers Squibb’s (BMS) Opdivo® (nivolumab) has had a new indication for resectable non-small cell lung cancer (NSCLC) listed on Australia’s Pharmaceutical Benefits Scheme (PBS).  It now joins MSD’s Keytruda® (pembrolizumab) in being listed on the PBS for treating NSCLC.

As previously reported, the application for this listing was considered at the Pharmaceutical Benefits Assessment Committee (PBAC) meeting in March 2024. BMS has also applied to have Opdivo® and Yervoy® (ipilimumab) listed for unresectable malignant mesothelioma.

The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024.

Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to Amgen’s Prolia®/Xgeva®) and Celltrion’s Steqeyma® (ustekinumab) (biosimilar to Janssen’s Stelara®).  Neither of these have yet received marketing approval.

Bayer is seeking listing on the Pharmaceutical Benefits Scheme (PBS) for an indication expansion for its Eylea® (aflibercept) for diabetic macular oedema and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).  MSD has applied for listing of a new strength of Ozempic® (semaglutide) (solution for injection 2 mg in 3 mL pre-filled pen) for type 2 diabetes.

Applications for PBS listing additions or amendments that the PBAC will consider at its November 2024 meeting include the following: