Oncology

Shanghai Henlius Biotech initiates a trial for patients with macular degeneration while Dong-A ST and Meiji Seika Pharma agree on a distribution plan for a ustekinumab biosimilar candidate.

China has approved a product for rheumatoid arthritis and Crohn disease that Mabpharm and Sorrento Therapteutics say is an improvement on infliximab.

An advertisement for the Onpro wearable pegfilgrastim injector kit has the potential to undermine sales of biosimilars, the FDA stated in a warning letter.

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

Chong Kun Dang of the Republic of Korea has entered a licensing deal for the distribution of a darbepoetin alfa biosimilar in the Gulf region.

Biosimilars are launching at significant discounts to reference products and capturing increasing market share, according to an Amgen report.

Top executives of JHL Biotech are alleged to have conspired to steal secrets for development of rituximab, bevacizumab, and trastuzumab biosimilars. Two co-conspirators have pleaded guilty in the case.

Following the release of a whitepaper on sustainable generics and biosimilars markets, members of a trade association discussed concerning trends for the industry.

In a white paper, the International Generic and Biosimilar Medicines Association (IGBA) describes industry dynamics that it says affect market sustainability and patient access.

Ahead of receiving regulatory approval for a "wet" age-related macular degeneration biosimilar candidate, a broad-based commercialization deal is inked.

The Center for Biosimilars® provided news and insight during June 2021 in the form of interviews with key opinion leaders and coverage of major events. Catch up on what you missed.

Teva and Bioeq partner on ranibizumab, Organon joins the Biosimilars Forum, and the Alliance for Patient Access issues educational material for oncology biosimilars.

The BIOSIM Act would increase the add-on payment for use of a biosimilar, thereby incentivizing practitioners to use these products more often, according to proponents of the bill.

Investigators reported high overall response rates and savings of roughly $1400 per patient across cohorts.

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.