Oncology

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.

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.