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Biosimilars Oncology Roundup: July 2022


Trials for denosumab biosimilars are ramping up and researchers are concerned whether patients with cancer switching to biosimilars have been adequately informed beforehand.

During July, progress on denosumab biosimilar candidates ramped up and a study raised concerns on whether patients with cancer were given adequate information prior to switching to a biosimilar.

Denosumab Boom: Fracture Prevention in Cancer Care

Study results from a phase 3 trial found that a denosumab biosimilar candidate developed by AryoGen Pharmed (Arylia) had comparable safety and efficacy profiles to the reference product (Prolia; Xgeva) in women with postmenopausal osteoporosis. Denosumab is used in the treatment and prevension of people at a high risk of fracture due to osteoporosis, solid tumors, and bone metastases.

Additionally, Alvotech initiated a pharmacokinetic study of its denosumab biosimilar, AVT03. Although the trial will include all men, future phases of the development process will include postmenopausal women to determine efficacy. AVT03 is Alvotech’s fourth biosimilar to reach the clinical trial phase of development.

A poster from the American Society of Clinical Oncology’s annual meeting demonstrated the safety and efficacy of QL1206 (Qilu Pharmaceiticals) compared to Prolia in patients with solid tumors and bone metastases, who were followed for 53 weeks. Each of the 717 patients received subcutaneous administration of the biosimilar or reference product.

Clinical Data on More Oncology Biosimilars

In addition to progress with denosumab biosimilars, data on oncology-specific biosimilars has been advancing too. A phase 1 trial of a pertuzumab biosimilar develop by Shanghai Henlius Biotech (HLX11) began in July. The trial represents the first human trial for the candidate and will focus on establishing HLX11’s pharmacokinetic, safety, and immunogencity profiles in health male adults in China.

Two studies presented at the European Hematology Association Congress 2022 demonstrated the safety and efficacy of 2 rituximab biosimilars compared to Rituxan (reference rituximab) in patients with large B-cell lymphoma. One study focused on Sandoz’ Riximyo over 2 years and the other looked at the use of a biosimilar in R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone).

Are Patients Being Adequately Prepared Before Switching to a Biosimilar?

A recent survey of patients with breast cancer and medical oncologists found that prior to switching from reference trastuzumab (Herceptin) to a trastuzumab biosimilar, patients may have not been given adequate education on biosimilars.

Many patients who switched to a trastuzumab biosimilar were not given prior notice that the switch would occur, resulting in the patients experiencing negative emotions related to the switch. Some patients were never told what a biosimilar was, and others only realized that a switch occurred after seeing a different name for the medication on their chart or insurance documents. Only 11% of the patients reported that they were satisfied with the information they received about biosimilars in preparation for the switch.

The survey also found that oncologists reported that they were not always aware that their patients were being switched to a biosimilar, because the decision was made by the health care system or insurance company. The researchers raised concerns that a lack of notification regarding a medication switch is an ethical issue, one that could add undue “emotional distress” to patients.

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