Tony Hagen

In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.

Investigators said the English health care system has realized only a sliver of the potential savings potential from biosimilar insulin glargine and that uptake is widely uneven across health care centers.

Investigators reported an 88% overall response rate for a Sandoz rituximab biosimilar in combination with chemotherapy in patients with CD20-positive diffuse large B-cell lymphoma.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Investigators produced what they described as the first evidence supporting the use of biosimilar erythropoiesis-stimulating agents (ESAs) in patients with myelofibrosis-related anemia.

Downward “drift” in batches of reference trastuzumab shed more light on the importance of antibody-dependent cell-mediated cytotoxicity on survival, investigators reported at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).

Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. An ongoing process may fix that.

Recognizing that oncology practices are struggling with the pandemic, the Center for Medicare and Medicaid Innovation has eased some performance requirements.

In a settlement announced via a Securities and Exchange Commission filing, Alexion said it had settled with Amgen over eculizumab patent disputes, allowing Amgen to bring a competing biosimilar to market in 2025.

A real-world study helped show how pegfilgrastim biosimilar can improve savings in the Oncology Care Model and its successor, the Oncology Care First Model, according to findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

After some delay, Revance and Mylan have decided to push forward with an FDA application for an onabotulinumtoxinA (Botox) biosimilar.

Shanghai Henlius Biotech received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization in 2 to 3 months.

The rituximab biosimilar candidate ABP 798 met primary and secondary end points for safety, efficacy, and immunogenicity in a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

Devika Das, MBBS, reviews the evidence presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology, and concludes that some deep reforms are needed in oncology care to improve access.

Prestige BioPharma of Singapore has successful clinical trials to support its bid to market a trastuzumab, based on findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

A study presented at ASCO20 Virtual demonstrated the power of biosimilar pegfilgrastim to lower costs in the Oncology Care Model (OCM), where pegfilgrastim expense amounts to 5.3% of the total cost of cancer care.

Fresenius Kabi has tapped pharmaceuticals distribution company medac to amplify sales of its pegfilgrastim biosimilar in Germany.

Fresenius Kabi USA announced that the FDA has accepted its biologics license application for the pegfilgrastim biosimilar candidate MSB11455.

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

On the heels of positive clinical studies, Fresenius Kabi said the European Medicines Agency will review its product application for a pegfilgrastim biosimilar.

Drug rebates have survived despite the payment reforms imposed by the Medicare Modernization Act of 2003, and now payers are taking advantage of them, too, panelists noted at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Annual Conference.

Patient preferences play a large role in the effort to get biosimilars into the mainstream of therapeutics, and education is often a struggle, panelists said at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Annual Conference.

A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.

A study of filgrastim and pegfilgrastim biosimilars demonstrated data are sufficiently large to support an investigation on the effectiveness of these agents.

In July 2020 Canada will implement a series of reforms to help bring runaway drug prices under control, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

The alternative payment model (APM) doesn’t perfectly balance the competing interests of revenue growth and value-based care, but it has been a learning tool, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Taiwan-based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate for bone loss.

Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.

There’s not enough study of the effects of international reference pricing, but it is likely to stifle innovation and create access problems, according to an expert panel at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.