Oncology

Potential developers of orphan drug biosimilars face daunting challenges to get these drugs approved and onto market, said a panel of experts.

EirGenix, in partnership with Sandoz, announced positive safety and efficacy results for its trastuzumab biosimilar in patients with breast cancer.

A renowned expert on the life sciences industry in the United Kingdom provides an insightful look at Brexit and the importance for the pharmaceutical sector.

A panel of physicians gave advice on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

Biosimilars get short shrift in a proposed pricing model developed by the Drug Pricing Lab at Memorial Sloan Kettering (MSK), experts say.

Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.

Biosimilars are intended to save money for the health care system, but for many reasons, they are not succeeding in this mission, Harvard authors argue.

Following lackluster experience with biosimilar marketing in the United States, Merck moves forward with spinoff plan.

Investigators observed early adoption of the trastuzumab biosimilar Kanjinti in patients with early breast cancer and metastatic breast cancer.

Pfizer said it has made a business decision to cease production of biosimilars at a $350 million plant it built recently in Hangzhou, China.

"Shocked" by the threat of competition, originator manufacturers start raising prices long before rival products appear on the scene, investigators found.

Alvotech closes on $35 million in funding, and Samsung Bioepis gets closer to marketing an adalimumab biosimilar. Alvotech's planned high-tech expansion is pictured.

The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Joseph Alvarnas, MD, a recent presenter at the Association of Community Cancer Centers annual meeting, discussed efforts to implement biosimilars at City of Hope, a clinical research center, hospital, and graduate medical school in Duarte, California.

Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, discusses motivating factors that affect use of biosimilars in oncology.

Survey results show that oncologists are embracing biosimilars not just in supportive care but for therapeutic uses also.

Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.

Lalan Wilfong, MD, an expert on value-based care, explains how Texas Oncology worked with physicians and payers to make biosimilars available for patients.

Investigators evaluated trial spending and reasons for biologics license application failures.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

In a review of trastuzumab treatment options, reviewers concluded subcutaneous (SC) vs intravenous (IV) options may be more costly and sometimes less practical.

Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer.

The Germany-based company with global operations plans to ramp up its biosimilars portfolio through 2025.

Although a more costly medicine, obinutuzumab proved more cost-effective over the long run than rituximab biosimilars in follicular lymphoma.

Gary H. Lyman, MD, PhD, provides an expert overview on overcoming the challenges of discussing biosimilars with patients.

Patient characteristics are predictive of whether a switch to a biosimilar is likely to be accepted, investigators found.

Biosimilar competition took a big chunk of revenue from Roche's aging blockbusters in 2020, and the company is banking on its newer medicines to drive fresh revenue growth.

Physician specialty and practice setting each play a significant role in whether biosimilars are administered vs originators, according to a large, cross-sectional study.