Oncology

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.

The biggest cost difference in filgrastim administrations was seen in the commercially insured population after the launch of a biosimilar, according to a study published Monday in Health Affairs.

The American Society of Clinical Oncology (ASCO) today released its third annual National Cancer Opinion Survey, results of which highlight the added stress that the financial burden of treatment places on patients with cancer.

Earlier this year, The Center for Biosimilars® staff sat down with our editorial advisory board member, Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center. In the interview, Abraham discussed how biosimilars have progressed in the United States over the past year, whether biosimilars are indeed delivering on their promised cost savings, and challenges that still lie ahead in the cancer space.

A new research report from Milliman, commissioned by the Leukemia and Lymphoma Society (LLS), found that fewer than half of patients with blood cancer received treatment within 3 months of diagnosis, and LLS says that costs may be keeping patients from getting care.

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

The less experience an oncologist has with administering rituximab, the more likely a Medicare beneficiary with non-Hodgkin lymphoma is to discontinue treatment, according to a new study. In addition, early rituximab discontinuation was associated with inferior lymphoma-specific and overall survival.

Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space. Christina Corridon, MPH, MBA, is a principal at the professional services firm ZS Associates, where she is a leader in ZS' oncology practice and leads their biosimilars vertical. She joined us to talk about the state of play in the US biosimilars market, what we can learn from ongoing experience, and how sustainable the US market for biosimilars may be today.

The International Society of Oncology Pharmacy Practitioners (ISOPP), which convened in London, United Kingdom, this week for its 18th international symposium on oncology pharmacy practice, has issued a new global position statement on biosimilars in therapeutic and supportive oncology.

The FDA has issued a complete response letter for Tanvex BioPharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen.

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

Biosimilar trastuzumab is becoming a feature of the biosimilar landscape in both Europe and the United States, with 5 agents (Herzuma, Kanjinti, Ontuzant, Ogivri, and Trazimera) approved in both territories and with additional biosimilars in the drugmakers’ pipelines. During the European Society for Medical Oncology (ESMO) Congress 2019, held in Barcelona, Spain from September 27 to October 1, researchers reported new data from phase 3 studies of 2 such biosimilar products.

During the European Society for Medical Oncology (ESMO) Congress 2019, researchers provided a detailed look at a 3-treatment, 6-sequence crossover study for a pegfilgrastim biosimilar, and a separate team presented on the use of biosimilar filgrastim in patients who are being given chemotherapy regimens that involve a rest period of up to 14 days.

In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.

This week on the podcast, we’re speaking with Jeffrey Patton, MD, chief executive officer of Tennessee Oncology, a partner practice of OneOncology, and the president of physician services for OneOncology. Patton shares with us the rationale for the adoption of biosimilars, how patients are responding, and lessons learned.

During this week’s European Society for Medical Oncology (ESMO) Congress 2019, held September 27 to October 1 in Barcelona, Spain, a research team presented findings from a phase 3 trial of Samsung Bioepis' SB8, a proposed bevacizumab biosimilar referencing Avastin.

During last week’s 22nd Annual Meeting of the Chinese Society of Clinical Oncology, held from September 18-22 in Xiamen, China, drug maker Innovent Biologics presented updated results for its proposed bevacizumab biosimilar, IBI305, in an oral session.

By providing time-saving options for treatment, Roche may be able to secure market share for its innovator biologics if savings in terms of chair time for patients are able to offset the eventual price discounts made available by biosimilar developers for their products.

Sandoz’s biosimilar filgrastim was first approved in Europe in 2009 under the name Zarzio (later, the same drug was approved as Zarxio in the United States). Since that time, the number of biosimilars approved for use in the oncology field has grown substantially, and a recent review says that the past decade of experience with biosimilar filgrastim underscores the strong scientific basis for the extrapolation of indications for biosimilars.

A new report released Monday by UnitedHealth Group finds that administering specialty drugs—which are typically injected or infused—in homes or in independent physician offices instead of hospitals could save as much as $4 billion each year.

Howard Burris, MD, FACP, FASCO, president of clinical operations and chief medical officer of Sarah Cannon Research Institute, discusses the adoption of oncology biosimilars.

China-based drug maker TOT Biopharm is developing TAB008 as a biosimilar of the reference bevacizumab, Avastin. TOT has recently indicated that it is in the midst of a phase 3 clinical trial of the biosimilar, and last month, results of a phase 1 study of the biosimilar were published in Frontiers in Pharmacology.

Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.

Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency.

“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”

The study in patients with non-Hodgkin lymphoma (NHL) is the second of a pair of studies intended to facilitate regulatory submissions for the proposed biosimilar.

When Samsung Bioepis’ trastuzumab biosimilar, SB3 (Ontruzant), gained regulatory approval in multiple highly regulated markets, it did so on the strength of a data package including evidence from a phase 3 study in patients with HER2-positive early breast cancer. Later, it became apparent that some of the patients who received the reference product in the phase 3 study had been exposed to lots of Herceptin with a marked shift in relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity.