Oncology

Innovent Biologics said based on success of ORIENT-32, China's National Medical Products Administration (NMPA) has approved sintilimab in combination with bevacizumab biosimilar (Byvasda) in front-line unresectable hepatocellular carcinoma.

Authors of an opinion piece suggest that a "reliance" approach to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.

Sizeable savings per patient with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) were anticipated by a Medicare savings model.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has favored marketing authorization for the ranibizumab biosimilar (Byooviz, SB11) based on phase 3 study findings.

A turning point for interchangeable biosimilars has arrived, as the first may be approved this year, but many questions about these agents have yet to be answered, according to Laura Sim, senior counsel for Amgen.

Investigators determine that converting at least 2 patients with metastatic breast cancer to a trastuzumab biosimilar could generate savings enough to treat a third patient.

Diverse findings on biosimilar safety and savings were presented at the American Society for Clinical Oncology (ASCO) 2021 Annual Meeting.

Investigators report survival data for the bevacizumab biosimilar Byvasda with sintilimab (Tyvyt) in hepatitis B virus–associated advanced hepatocellular carcinoma (HCC).

Real-world evidence from Poland and Brazil confirms comparable safety for the trastuzumab biosimilars Kanjinti and Zedora in the breast and gastrointestinal cancer settings.

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

Amneal Pharmaceuticals develops its biosimilar pipeline with mAbxience, Xcenda estimates biosimilar effect on originator pricing, and Magellan Rx Management touts oncology biosimilars savings.

The “winner-takes-all” tender process for biosimilar procurement in the European Union runs the risk of driving competitors out of the market, authors of a new survey contend.

Same-day pegfilgrastim to combat febrile neutropenia in conjunction with myelosuppressive chemotherapy (CTX) is safe, investigators conclude.

Postmarketing retrospective studies of the rituximab biosimilar (CT-P10, Truxima) demonstrated comparable safety and efficacy for treatment of diffuse large B-cell lymphoma (DLBCL).

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.

In part 2 of this panel discussion, 3 experts on India’s biologics industry discuss whether biosimilars can be produced affordably in the country and ways of improving the industry’s image.

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally.

Reverse switching occurs when patients transitioned to or initiated on a biosimilar are changed to an originator product, often because of a perceived failure in the biosimilar therapy.

Investigators noted a reduction in use of high-cost supportive care agents, suggesting that the value-based Oncology Care Model (OCM) is working.

Investigators further elucidate the equivalence of a trastuzumab biosimilar vs Herceptin in human epidermal growth factor receptor 2–positive (HER2+) breast cancer.

When biosimilars emerged in oncology, oncologists dipped in a toe and then got serious, according to a retrospective study on usage and savings presented at ASCO 2021.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.

The substitution program was carried out in 2020 and yielded savings of $4 million in 1 month, investigators reported at ASCO 2021.

Immunogenicity was rare but concerning for patients who switched from originator rituximab to the biosimilar Riximyo, investigators reported.

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

In part 2 of this interview, Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, discusses the potential for interchangeable insulin biosimilars and the challenges of obtaining reliable and optimized real world data.

More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

Wider use of granulocyte colony-stimulating factor (G-CSF) biosimilars is recommended for patients at risk of febrile neutropenia (FN).

The pandemic interrupted health care for many patients and saddled health care institutions with high costs. How might biosimilars improve conditions?