Sandoz, Bio-Thera Solutions Enter Deal to Commercialize Avastin Biosimilar

Chinese biosimilar maker Bio-Thera Solutions has signed a commercialization and license agreement with Germany–based Sandoz to commercialize BAT1706, a bevacizumab biosimilar candidate referencing blockbuster reference product Avastin (Genentech).

Bevacizumab is a monoclonal antibody that acts as an inhibitor for vascular endothelial growth factor used to treat several forms of cancer, including advanced, metastatic, or recurrent non-small cell lung cancer, metastatic colorectal cancer and certain types of renal cell carcinoma, ovarian cancer, cervical cancer, and glioblastoma. Bevacizumab products are also commonly used in combination therapies.

“Bio-Thera Solutions is happy to enter this agreement with a global biosimilar leader to bring BAT1706, our bevacizumab biosimilar, to patients around the world….Biosimilars are an important aspect of Bio-Thera Solutions corporate strategy and a critical to increasing patient access to innovative products like bevacizumab,” said Shengfeng Li, PhD, CEO of Bio-Thera, in a company statement.

Under the agreement, Bio-Thera will be responsible for development and manufacturing of BAT1706. Sandoz will possess the commercialization rights for the United States, the European Union, Canada, and a select list of other countries.

Additionally, Bio-Thera will receive an upfront payment followed by subsequent milestone payments and is entitled to receive profit share payments in the territories Sandoz will be marketing the product in, according to a statement released by Sandoz.

More on BAT1706 and Bio-Thera

Bio-Thera filed for marketing authorization in the European Union in November 2020 and a biologics license application for FDA approval is pending. In June 2020, an application for BAT1706 was accepted by China’s National Medicinal Products Administration (NMPA), propelling the product 1 step closer to regulatory approval. The company also applied for approval in Brazil in December 2020.

In addition to BAT1706, Bio-Thera is running a phase 3 trial for its ustekinumab biosimilar candidate (BAT2206) referencing Stelara (Janssen Biotech) for the treatment of plaque psoriasis and psoriatic arthritis. In August 2021, the company announced a commercialization agreement with Hikma Pharmaceuticals for BAT2206, which is based in the United Kingdom.

Bio-Thera began a phase 3 trial for its golimumab biosimilar candidate (BAT2506) referencing Simponi. Golimumab is used as a therapeutic treatment for psoriatic arthritis. The company is partnering with Pharmapark, a Russian biopharmaceutical company, to commercialize BAT2506 in Russia.

In January 2020, Bio-Thera launched its adalimumab biosimilar (BAT1406) in China. BAT1406 references Humira (AbbVie) and it was the first adalimumab biosimilar to receive approval from the NMPA.

More on Sandoz’ Biosimilar Products

In May 2021, Sandoz began a phase 3 trial assessing the efficacy and safety of its aflibercept biosimilar candidate referencing Eylea, which was developed by Regeneron. Aflibercept is used to treat a number of ophthalmic conditions, including neovascular age-related macular degeneration, diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other neovascular retinal diseases.

Sandoz’ Canada division has also launched 5 biosimilars on the Canadian market, including Hyrimoz (adalimumab), Ziextenzo (pegfilgrastim) and Riximyo (rituximab), Omnitrope (somatropin), and Erelzi (etanercept).

Pegfilgrastim (reference product, Neulasta; Amgen) is used as a prophylaxis for febrile neutropenia in patients with cancer undergoing chemotherapy and rituximab (reference product, Rituxan; Genentech) is used for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Omnitrope, which references Serostim, is used in patients with growth hormone deficiencies, and although the product is marketed in the United States, it is not considered a biosimilar because it was approved prior to the existence of a biosimilar approval pathway. Erelzi, which references Enbrel, is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis.