Biosimilars

Brazilian oncologists showed a solid knowledge base about biosimilars and their safety; however, concerns over extrapolation and interchangeability requirements remained, suggesting that more education on these subjects is needed.

Regulatory agencies have already begun calling companies out for misdirecting the public about the safety and efficacy of reference products in comparison to biosimilars, and it's important to continue to do so, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Bevacizumab biosimilar LY01008 demonstrated comparative safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product Avastin when combined with paclitaxel and carboplatin in patients with non–small cell lung cancer (NSCLC).

The emergence of new COVID-19 variants and the lower-than-anticipated vaccination rates could lead to a greater use of pegfilgratim biosimilars in cancer settings, explained Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Byooviz becomes the first FDA-approved ophthalmology biosimilar and the first FDA-approved biosimilar referencing Lucentis (ranibizumab), according to a statement from developers Samsung Bioepis and Biogen.

Cost and lack of insurance are big drivers of why a physician may choose to prescribe a pegfilgrastim biosimilar over the convenient on-body device for the originator, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

Samsung Bioepis found during a 5-year follow-up study that Ontruzant, the company’s trastuzumab biosimilar, had comparable cardiac safety and long-term efficacy with the reference product Herceptin.

Reducing the risks of secondary neutropenia, exposure to COVID-19, mortality, and financial toxicity were all major reasons the use of pegfilgrastim biosimilar gained traction during the pandemic, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care.

Bio-Thera Solutions and Sandoz have partnered for to allow for the commercialization of BAT1706, a bevacizumab biosimilar referencing Avastin, for the treatment of several forms of cancer.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, discussed physician anticipation for the first biosimilars for programmed death (PD)-1 inhibitors.

Switching from Herceptin (reference trastuzumab) to trastuzumab biosimilars could significantly reduce direct medication costs attributed to breast cancer management in Saudi Arabia, researchers concluded.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, talks about the anticipation for more biosimilars to enter the oncology market and the current level of interest in the pipeline.

In comparison with reference rituximab (Rituxan), the use of rituximab biosimilars in combination therapy produced similar 3-year overall survival among patients with large-B-cell lymphoma (DLBCL), investigators concluded.

Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, this study found that site of care can change this calculus, reducing savings.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, discusses the potential for biosimilar utilization to grow and the reasons why his practice favors them over reference products.

Switching patients from reference pegfilgrastim to a biosimilar could lead to substantial cost savings, with potential to offset the cost of and allow for greater access to chemotherapy treatment, investigators concluded.

A 2020 trends report from Artemetrx showed how biosimilar competition has contributed to lower average sales prices and claim percentages for originator products, suggesting that biosimilars are making a difference despite slow uptake.

Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, talks about the importance of conducting regular evaluations to ensure that prescribing the most cost-effective option, whether that be a biosimilar or the reference product.

In one of the first studies to examine real-world evidence on rituximab biosimilars in the United States, investigators found that many providers treating patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) are regularly prescribing a biosimilar rituximab.

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how financial incentives, concerns for patients, and interchangeability impact biosimilar prescribing patterns.

Two oncologists dive into the reasons behind physician hesitancy and unwillingness to prescribe biosimilars to patients with cancer and make suggestions on how to increase confidence in these agents.

Gary Lyman, MD, MPH, an oncologist and hematologist, compares the uptake of filgrastim biosimlars with pegfilgrastim biosimilars.

Amgen has received a letter from the FDA cautioning it against making misleading claims in advertising about its pegfilgrastim injector.

Gary Lyman, MD, MPH, an oncologist and hematologist, gives his thoughts on whether health care institutions need to be doing more to encourage use of biosimilars.

The price of reference products reduced each time a new biosimilar was added to a drug program’s reimbursement list, supporting the notion that reimbursing biosimilars creates more competition and lowers drug costs, according to a Polish study.

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how biosimilars have fared in the oncology space compared to other therapeutic areas.

Twenty-eight patient advocacy groups wrote a letter pledging endorsement of the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act, a bill aimed at increasing reimbursement and incentivizing prescriptions for biosimilars.

Ivo Abraham, PhD, RN, a professor with the University of Arizona Health Sciences in the Department of Pharmacy Practice, discusses how the COVID-19 pandemic is likely to impact oncology biosimilar utilization.

Ivo Abraham, PhD, RN, a professor with the University of Arizona Health Sciences in the Department of Pharmacy Practice, talks about the role that the pandemic has played in the struggle between biosimilar pegfilgrastims and the on-body injector version of the reference product.

A report from Xcenda showed that biosimilars for 8 blockbuster reference biologics have successfully kept drug prices from increasing by an average of 56%, restoring the possibility that biosimilars could achieve significant discounts despite facing several barriers to uptake.