Oncology

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?

An antibody conjugate, Ujvira combines the cancer cell growth–fighting properties of trastuzumab with the cytotoxic capability of emtansine.

China’s streamlined system for biologics approvals has enabled Shanghai Henlius Biotech to bring biosimilars to market faster and potentially at a lower cost, Ping Cao, vice president of Business Development, explains.

Prestige BioPharma aims to expand its drug pipeline with a $152 million research and development facility.

Biosimilar education can increase physician motivation to prescribe these alternatives to costly originator products, panelists said in a Sandoz/Reuters discussion.

Accused of unfair trade practices, AbbVie's CEO Richard Gonzalez pointed the finger at Medicare Part D.

The retrospective, real-world study (N = 353) conducted within the Kaiser Permanente network followed the July 2019 launch of the bevacizumab biosimilar Mvasi.

The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination.

A Canada study of the filgrastim biosimilar Grastofil demonstrated equivalence to Neupogen in candidates for autologous stem cell transplantation (ASCT), an extrapolated use.

A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.

With COVID-19 on the retreat, Coherus BioSciences sees the advantage wearing off for Amgen's pegfilgrastim injector kit.

This is the third and final part of our series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders.

Advances in analytical testing have improved confidence in biosimilars, according to a Medicines for Europe panel.

The anatomy of an interchangeability switching study.

Biosimilar companies partnered with other companies and saw earnings increases, while reference product corporations faced sales erosion from biosimilar competition.

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.

Biocon tests the waters with itolizumab in pandemic-ravaged India, and Celltrion announces early success with an agent for the South African variant.