BioBlast®

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 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.

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung’s application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung’s 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan’s Mvasti® in January 2018 and Pfizer’s Zirabev® in December 2018). Centus Biotherapeutics’ application for Equidacent® follows Samsung’s closely, having received CHMP positive opinion in July 2020.

Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin®.

Amgen/Allergan announce the EMA’s CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more