Oncology

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

We spoke to Charles Bennett, MD, PhD, a clinical pharmacy specialist, about his recent oncology biosimilars study and how pay-for-delay schemes have somewhat stalled the biosimilar market.

Pharmacokinetic (PK) parameters matched up with those of reference trastuzumab in an extended analysis of data from the HERITAGE trial.

Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.

Ivo Abraham, PhD, RN, a professor with the University of Arizona Health Sciences in the Department of Pharmacy Practice and a health care consultant and co-founder of Matrix45, discussed how the pandemic is likely to impact the use of pegfilgrastim biosimilars.

Among patients treated for metastatic breast cancer, 40% switched to ABP 980.

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.

Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.

In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020.

MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.

The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape.

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.

Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.

The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.

An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.

Two studies of trastuzumab biosimilars have improved understanding of these medicines as monotherapy and in combination with other agents in metastatic breast cancer.

The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.

Investigators explained the potential for durable antitumor efficacy in patients with human epidermal growth factor receptor 2 (HER2)-expressing or -driven tumors who have exhausted other treatment options.

A high overall response rate of 93% was observed for patients with immune thrombocytopenic purpura who received romiplostim biosimilar.

A long-term, comparative, phase 3 trial of CT-P10 vs the rituximab originator product has provided evidence of biosimilar value in this blood disorder.

The wearable injector has a failure rate that adds hospitalization costs; therefore, biosimilar pegfilgrastim may hold cost advantages, investigators conclude.

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach.

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.