Oncology

Health Canada approves Ontruzant, the fifth Samsung Bioepis biosimilar to be approved for the Canadian market.

The authors noted that “all biologic therapeutics can be immunogenic or elicit an immune response,” and that an assessment of immunogenicity is part of the totality of evidence required for regulatory approval of biosimilars.

US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

Two biosimilars, Pfizer’s Zirabev and Amgen’s Mvasi, have been approved for indications including unresectable, locally advanced NSCLC and recurrent or metastatic nonsquamous NSCLC. BI 695502 is no longer under development by Boehringer Ingelheim.

Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Ford Motor saved $5 million by switching patients to 5 biosimilars, and other manufacturers and employers in Michigan have achieved good results with switching programs, the Economic Alliance of Michigan reports.

Amgen Chairman and CEO Robert Bradway touted the potential of 11 biosimilars anticipated to be driving revenues for the company by 2030.

In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.

Savings from adalimumab biosimilars, which won't enter the US market until 2023, account for a significant share of the total, investigators said.

Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

With fewer of the risks associated with novel drug development, biosimilar candidates allow manufacturers to plan far into the future for marketing needs.

In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.

Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products.

Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.

In metastatic breast cancer (mBC) resistant to multiple lines, Herzuma (a trastuzumab biosimilar) plus gedatolisib, an mTOR/PI3K signaling pathway inhibitor, demonstrated value.

After a switch to a biosimilar, patients and their oncologists may not always agree on how well the switch was described or whether the patient felt involved.

Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.

Tot Biopharm receives China regulatory approval for a bevacizumab biosimilar and Fujifilm moves forward with plans for a Suzhou Innovation and Collaboration Center.

The trial included "drifted" (nonstandard) reference product, forcing a stratified analysis to yield relevant data.

Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).

The arrival of biosimilars for filgrastim and pegfiltrastim coincided with higher use of granulocyte colony-stimulating factor (G-CSF) for prophylaxis against febrile neutropenia, but many high-risk patients still do not receive the treatment.

A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.