Oncology

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
 
Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.
Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.
The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.
Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.
Spain-based drug maker mAbxience is developing a biosimilar rituximab, RTXM83. Last week, researchers reported findings from a head-to-head study of the proposed biosimilar versus its reference product as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).
With trastuzumab biosimilars expected on the US market soon for HER2-positive breast cancer, an advocacy organization for patients with breast cancer said recently that it wants to provide education about the potential of the medicines to lower costs and provide more treatment options.
The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.
The investigators found that the biosimilar and the reference in combination with a subdomain II–targeting antibody had similar in vitro inhibition rates for HER2 and HER3 heterodimerization.
Under the approach used by Kaiser Permanente, say the authors, in which oncologists have salaried incomes and are not reimbursed on a relationship to drug price, far higher generic uptake has been observed.

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