The Center for Biosimilars

Anti—tumor necrosis factor biosimilars for the treatment of inflammatory disease present attractive cost savings for both payers and patients. A free, continuing education broadcast on September 29, 2020, at 8 p.m. will address the identification of patients most likely to benefit from biosimilars for inflammatory conditions, review current clinical evidence and real-world data on the use of these agents, and demonstrate how to develop evidence-based protocols for reducing expenditures and improving access to these treatments. This program is for managed care pharmacists and other interested clinicians and will be presented by Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars for Cardinal Health. For more information or to register for the "Treating Inflammatory Conditions With Biosimilars" symposium, please click 

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A September 29, 2020, symposium with Sonia T. Oskouei, PharmD, BCMAS, DPLA, of Cardinal Health will explore how to incorporate biosimilars into the treatment of inflammatory conditions. 

Symposium: Treating Inflammatory Conditions With Biosimilars

The FDA has approved 28 biosimilar products, 16 of which have indications for patients with cancer. These include versions of the monoclonal antibodies trastuzumab, bevacizumab, and rituximab, as well as biosimilars for the supportive care agents pegfilgrastim, filgrastim, and epoetin-alfa.

Integrating biosimilars further into cancer care will require an educational outreach, according to Ali McBride, PharmD, MS, BCOP, clinical coordinator of Hematology and Oncology in the Department of Pharmacy at the University of Arizona Cancer Center and immediate past president of the Association of Community Cancer Centers (ACCC).

 with OncLive.com, he discusses the age of biosimilars, the ACCC’s initiative to broaden acceptance and use of these drugs, and the knowledge gaps that need to be filled to ensure biosimilars are properly understood.

Ali Mcbride, PharmD, MS, BCOP, is taking a lead role in promoting the use and understanding of biosimilars in oncology.

ACCC's McBride on the Need for Biosimilar Education

Having 5 trastuzumab biosimilars with indications for HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma illustrates the increasing role of these more cost-effective treatments.

Ruth O’Regan, MD, believes the evidence indicates these agents are similar in efficacy and safety to the originator drugs, and for this reason they should be employed more often by providers and patients.

In this way, the problem of financial toxicity can be diminished, said O’Regan, a professor of medicine in the Division of Hematology and Oncology at the University of Wisconsin School of Medicine and Public Health and associate director for Clinical Research at University of Wisconsin Carbone Cancer Center in Madison.

In a recent interview, O’Regan discussed access to biosimilars, the provider-patient conversation about using these drugs, and education issues that must be surmounted.

Currently, much of the power over drug choice belongs to payers, she said. “At the end of the day, we don’t make the decisions on which drugs to use.” She said she’s confident that payers will naturally be interested in biosimilars because they offer potential savings and, for this reason, biosimilars are going to become more and more available. She anticipates that at Carbone biosimilars are going to have a “very profound effect” on the costs of care.

For reasons of cost, it may be preferable to switch patients from more costly reference drugs to biosimilars. “They may be apprehensive to go on an alternative drug. However, we may have no option. We’re developing educational information for the patients so that they understand these drugs are essentially the same,” O’Regan said.

Knowing how to discuss biosimilars with patients is, therefore, important, she said. For starters, patients should be told that these drugs are the same, essentially, and that they cost less. Although biosimilars are intravenous formulations and look different from generic pills, for example, patients should know that there is no reason to believe that they wouldn’t be just as effective, she said.

“We need to reiterate that these drugs have been tested and they look exactly the same as the parent drug,” O’Regan said.

For patients just starting out with treatment, there’s likely to be less resistance to initiating with a biosimilar. “For patients with metastatic disease who are very dependent on [reference] drugs and have been doing well, it may be a little trickier.” In such an instance, bringing the pharmacist into the examination room to help explain that biosimilars are equivalent may be a useful strategy, she said.

The National Comprehensive Cancer Network (NCCN) has been a helpful advocate for biosimilars for several years now, O’Regan said. “This is very much on their radar. What the NCCN recommends will impact what is being done on a national level.”

Ruth O’Regan, of the University of Wisconsin Carbone Cancer Center, discusses improving the patient discussion on biosimilars, in an interview.
 

Carbone Professor: Biosimilars Have Important Role to Play

With 1 biosimlar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries has 

 higher biosimilar revenues for the first quarter of 2020 compared with the same time last year.

Biosimilar income helped to offset declines in revenue from generic products in the first quarter for Teva. For both categories, however, revenues were $952 million for the first quarter of 2020, which is down 1% compared with the first quarter of 2019.

The company attributed the decline to price erosion for its products and lower royalty income, offset by an increase in revenues from launches of new products, including the rituximab biosimilar Truxima. Revenues for Truxima were not disclosed.

Truxima was launched in November 2019 for the treatment of CD20-positive, B-cell non-Hodgkin lymphoma either as monotherapy or in combination with chemotherapy. Following the resolution of a patent dispute, the product became 

 this month for treatment of rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Overall, Teva's revenue for the first quarter of this year was $4.4 billion, which is an increase of 5% versus the year-ago quarter.

“Our very strong results during the first quarter of 2020 were impacted by greater demand in our major markets for generic and [over-the-counter] products and respiratory products,” said Kare Schultz, Teva’s president and chief executive officer.

The company reported net income for the quarter of $69 million, up from a loss of $105 million in the year-ago quarter.

In March of this year, Teva launched its trastuzumab product, Herzuma, in the United States. At present, the company has multiple biosimilars in preclinical and phase 1 development.

Teva has undergone a large-scale restructuring over the past 2 years, during which it sought to cut spending, reduce its workforce, and close manufacturing sites. For the quarter just ended, Teva said it had reduced its debt load by $600 million, leaving $24.3 billion in accounts payable.

With 1 biosimilar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries reported higher biosimilar revenues in the first quarter of 2020.

The Center for Biosimilars

Symposium: Treating Inflammatory Conditions With Biosimilars

ACCC's McBride on the Need for Biosimilar Education

Carbone Professor: Biosimilars Have Important Role to Play

Teva Moves Further out of Debt and Gains Biosimilar Revenue