Oncology

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

Indication-based pricing is a method used to reimburse drug makers according to a drug’s indication-specific value when the drug has multiple indications. A number of healthcare payers have already implemented or are planning to implement IBP, including Express Scripts, the largest US pharmacy benefit manager.

The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35% higher than it was in 2014, according to pharmacy benefit manager Express Scripts.

Complete phase 3 data show that a biosimilar almost beat reference trastuzumab (Herceptin) for the primary endpoint of pathologic complete response in patients with HER2-positive early breast cancer.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.

Medicines for Europe says that the sustainability of healthcare budgets in European nations has been “intensely pressured” in recent years by factors including an aging population and the introduction of high-cost drugs, and that governments aiming to address those challenges have resorted to austerity measures that have “driven the prices of some off-patent medicines to unsustainably low levels."

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.

The standard way to conduct mobilization in hematopoietic stem cell donors relies on using 2 original granulocyte-colony stimulating factors (G-CSFs), filgrastim (Neupogen) and lenograstim (Granocyte).

September was a busy month for oncology biosimilars: the first anticancer biosimilar was approved in the US, new data showed promising momentum for additional therapies, and patent litigation yielded costly results for one biosimilar developer.

Republican efforts to repeal and replace the Affordable Care Act may have stalled once again with the failure of the Graham-Cassidy bill on Thursday, but advocacy groups intend to keep healthcare—and the high cost of prescription drugs—at the forefront of Congress’ agenda.

The rituximab biosimilar CT-P10 (Celltrion and Teva’s Truxima), which is approved in the European Union and under review by the FDA in the United States, showed comparable effectiveness to reference rituximab (Genentech and Biogen’s innovator product, sold as Mabthera and Rituxan) in a network meta-analysis.

The FDA has approved, to date, 7 biosimilar treatments.

In real-world community oncology settings, bevacizumab-containing regimens were associated with longer progression-free survival and overall survival compared with non-bevacizumab regimens.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharamcy Specialist, discusses the merits of the current biosimilar naming system.

Kashyap Patel, MD, Medical Oncologist, Carolina Blood and Cancer Care, discusses the potential impact of biosimilar drugs on Medicare Part D drug pricing.

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions on 2 biosimilar candidates.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 11.

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

Adello Biologics, a New Jersey-based biosimilar developer previously named Therapeutic Proteins International, announced this week that its Biologics License Application (BLA) for a biosimilar filgrastim candidate has been accepted for review by the FDA.

According to a new study, potential savings realized from transitioning to treatment with biosimilar filgrastim-sndz from reference filgrastim are not only significant, but these savings can also be applied to expand access to novel immunotherapies or supportive care.

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

On Tuesday, leaders of patient advocacy groups presenting at the 2017 AAM Biosimilars Council Conference had a clear message for industry: biosimilar uptake will only happen in earnest when patients begin to see savings on their out-of-pocket treatment costs.

Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.

Sandoz announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed rituximab biosimilar. The drug is referenced on Rituxan, which is approved to treat blood cancers and immunological diseases.

Three posters presented on September 10, 2017, at the European Society for Medical Oncology (ESMO) 2017 meeting in Madrid, Spain, covered research on 2 proposed pegfilgrastim biosimilars and evaluated the use of filgrastim in oncology practice.

How much money can biosimilar filgrastim save, and how can health systems encourage uptake? This infographic outlines 7 key concepts.

Oncology trials often report on progression-free survival or overall survival, but the authors of an analysis presented during a poster session today at the European Society of Medical Oncology (ESMO) Congress argue that such endpoints are less sensitive then short-term overall response rate.

Poster presentations at this week’s European Society for Medical Oncology (ESMO) conference include the results of 5 studies on biosimilar trastuzumab candidates.

Bruce A. Feinberg, DO, CMO, Cardinal Health Specialty Solutions, discusses biosimilar labeling and concerns with extrapolation.