On 9 August 2024, New Zealand’s Pharmaceutical Medicines Agency (Pharmac) announced that it is seeking commercial bids from suppliers for the supply of bevacizumab for a range of cancers.

Bevacizumab is currently funded in NZ hospitals for recurrent respiratory papillomatosis, ocular neovascularisation and exudative ocular angiopathy.  Pharmac is now seeking funding applications for its use in hepatocellular, colorectal, ovarian and cervical cancers and glioma.

Pharmac states that it is following a competitive procurement process “because there are multiple potential suppliers of bevacizumab in New Zealand”.  Roche’s Avastin® (bevacizumab) has been approved in New Zealand since 2009 and is currently indicated for a range of cancers.  Bevacizumab biosimilars have been approved in New Zealand for Amgen (Mvasi®, 2021), Pfizer (Zirabev®, 2021), Biocon/Maxx Pharma (Abevmy®, 2022) and Celltrion (Vegzelma®, 2024).

A study evaluating results from a Phase 3, randomised, double blind trial sponsored by Samsung Bioepis was published on 16 January 2023 in the journal, Frontiers in Pharmacology. The results show that Samsung Bioepis’ SB8 (bevacizumab biosimilar) had a comparable efficacy to Genentech’s Avastin® (bevacizumab) for treatment of non–small cell lung cancer.

On 24 January 2024, the Therapeutic Goods Administration (TGA) approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab), to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support mAbxience’s MB02 bioequivalence to Genentech’s Avastin® (bevacizumab) (EU and US).  No clinically meaningful differences in safety or immunogenicity were observed.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

The Korea Times has reported Celltrion has reported a Q1 2023 net profit of ₩167.1B (US$126.4 million).  Celltrion said in a regulatory filing that operating profit for Q1 rose 41.1% on-year to ₩182.4B, and revenue increased 12.4% to ₩597.5B.

In April 2023, Celltrion launched Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, in the US, and in May 2023 Celltrion won bids to supply Vegzelma in Italy and Belgium.

Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC).  The sNDA is based on results of a phase III clinical trial which combined Lonsurf® with Genentech’s Avastin® (bevacizumab), which saw improved survival and progression-free survival over Lonsurf® alone.  The FDA expects to decide on the sNDA by 13 August 2023.

Last year Genentech and Samsung Bioepis settled their US BPCIA Avastin® bevacizumab patent dispute.

Biocon announced that the FDA has issued a Complete Response Letter for Viatris (Mylan)’s BLA regarding the bevacizumab jointly developed with Biocon Biologics (biosimilar to Genentech’s Avastin®).  Biocon Biologics said in the announcement that is has submitted a comprehensive Corrective and Preventative Action plan, and is confident of addressing the observations within the stipulated timeframe.

Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal.  The Lams plead guilty to stealing confidential intellectual property relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab) and Avastin® (bevacizumab), passing the information onto JHL Biotech to aid in its biosimilar development.

Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims.  Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 patents relating to bevacizumab (Avastin®).  No further details about the settlement agreement have been disclosed.

The American Academy of Ophthalmology pushed back against insurance company pressure to use new bevacizumab biosimilars off-label in eye treatment as alternatives to Avastin® (bevacizumab) in the absence of supporting studies.