Oncology

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.

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.

Jorge Garcia, MS, assistant vice president of the System Oncology Pharmacy Service Line at Baptist Health South Florida, discussed how the pandemic has interrupted oncology care for patients and affected the utilization of pegfilgrastim biosimilars.

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

Kathy Oubre, MS, chief operating officer at the Pontchartrain Cancer Center in Louisiana, discusses the value of biosimilars.

Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.

Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.

Launched in the US market in late 2019, Truxima (rituximab) has become a significant revenue driver for Teva.