On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.

AstraZeneca has announced that its Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been approved in the EU as treatment for certain patients with primary advanced or recurrent endometrial cancer.  This approval follows the recommendation by the EMA’s Committee for  Medicinal Products for Human Use (CHMP), which was based on DUO-E Phase II results last month.

AstraZeneca’s report also mentions that regulatory submissions for Imfinzi® and Lynparza® are currently under review in Japan and several other countries based on the DUO-E trial.  The FDA also recently approved Imfinzi® (durvalumab) plus chemotherapy for dMMR patients with primary advanced or recurrent endometrial cancer.

AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer. 

New and expanded Pharmaceutical Benefits Scheme (PBS) listings are to be implemented in Australia for AstraZeneca/MSD’s Lynparza® (olaparib), expanded for use for patients with human epidermal growth factor receptor 2 negative (HER2-negative) high-risk early breast cancer with specific gene mutations, and AstraZeneca’s Saphnelo® (anifrolumab), listed for the first time to treat the severe systemic form of lupus erythematosus (SLE) in patients with high disease activity despite standard treatment. 

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatment.  Between 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/Merck’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab, is advanced (stages 3 and 4) and is HRD positive (BRCA1 or BRCA2 mutation or genomic instability).

On 24 August 2023, AstraZeneca announced the Japanese MHLW expanded the approval for Lynparza® with abiraterone to treat BRCAm mCRPC.

AstraZeneca and Merck announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the indication for Lynparza® (olaparib), to be used alongside abiraterone and prednisolone for adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer showcasing distant metastasis (mCRPC).  Lynparza® is the first PARP inhibitor approved in Japan demonstrating significant benefits in tandem with a new hormonal agent.

On the same day AstraZeneca also announced the MHLW expanded approval for Soliris® (eculizumab) to treat paediatric patients with gMG.

The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or prednisolone) for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.  Following this approval, AstraZeneca announced that it will receive a regulatory milestone payment from MSD, anticipated to be confirmed in Q2 2023 results. 

This news follows the FDA’s Oncologic Drugs Advisory Committee vote to support FDA approval of Lynparza® with abiraterone and prednisone (or prednisolone) for the above indication in April 2023.  

Merck announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support FDA approval of Lynparza® (olaparib) plus abiraterone and prednisone or prednisolone for the first-line treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).  ODAC voted against approval for the combination beyond this patient population.

Lynparza® is currently approved in the US for patients with homologous recombination repair gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.  It is also approved for the treatment of ovarian, breast and pancreatic cancer.  The first line combination use is approved in Europe for mCRPC patients in whom chemotherapy is not clinically indicated.

AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.