Biosimilars for cancer treatment on the U.S. horizon

August 10, 2016

Cancer treatments are expected to dominate much of the first wave of biosimilars in the U.S. This Q&A discussion looks at some of the questions pharmacists have about use of biosimilars in cancer treatment.

Cancer treatments are expected to dominate much of the first wave of biosimilars in the U.S., prompting a slew of questions from patients and physicians about these alternative medications.

Ali McBrideOnce they learn about biosimilars themselves, pharmacists will play a crucial role in providing answers about these unique drugs. “There will be many years of education in regard to this discussion,” predicts Ali McBride, PharmD, MS, BCPS, BCOP, clinical coordinator of Hematology/Oncology with the University of Arizona Cancer Center. “But I don’t think it will be a headache.”

In fact, he says, the rise of biosimilars will be a boon for community pharmacists who want to help patients gain access to medications by reducing costs. More access, of course, will translate to more revenue for pharmacists.

For the moment, however, medical professionals are focusing on the complexities of this new age of cancer biosimilars.

Here are some questions and answers for pharmacists as biosimilars for cancer begin to enter the market.

DT: Are cancer biosimilars on the market now?

A: Only one has been approved: Zarxio (filgrastim-sndz), which is now allowed in the U.S. as an alternative to Neupogen (filgrastim).

 

The drug, the first biosimilar to receive FDA approval, is a bone marrow stimulant that helps prevent infections in cancer patients during treatment. It’s approved for patients with cancer receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; those with cancer undergoing bone marrow transplantation; those undergoing autologous peripheral blood progenitor cell collection and therapy; and those with severe chronic neutropenia.

Two other biosimilars have been approved since the approval of Zarxio in March 2015.

One is the infusion drug Inflectra (infliximab-dyyb), approved for multiple indications, such as rheumatoid arthritis, as a biosimilar alternative to Remicade. There have been rumblings that Remicade’s manufacturer will try to head off the biosimilar’s availability in court.

The other approved biosimilar is Basaglar (insulin glargine injection), a diabetes medication considered to be similar to Lantus.

Manufacturers are working toward more approvals. As of late January, 59 proposed biosimilar medications-akin to 18 biologics-were enrolled in the FDA’s Biosimilar Product Development program.

DT: What’s next for cancer biosimilars?

A: According to Amgen’s 2015 Trends in Biosimilars Report, cancer biologics with biosimilars under development included Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab).

 

When they reach approval in the U.S., as seems likely, biosimilars for cancer will certainly draw extra attention from pharmacists and other medical professionals.

“We will all be a little cautious about biosimilars for drugs that are for treating cancer, particularly in the adjuvant setting where cure is still possible,” says Sarah L. Scarpace, PharmD, MPH, BCO, an associate professor of Pharmacy Practice with the Albany College of Pharmacy and Health Sciences. “Over time, however, we will have more information and greater confidence as data will be collected and shared through the Biologics and Biosimilars Collective Intelligence Consortium.”

DT: Biosimilars may be approved even if they haven’t shown clinical efficacy for each of the indications of the original biologics. Should pharmacists worry about using biosimilars for all the indications?

A: “Some physicians and pharmacists may initially be hesitant to use these new drugs in indications for which they have not been tested, but the FDA has decided that if the drug is ‘highly similar’ in structure, preclinical testing, and clinical testing in one indication, then physicians/pharmacists should feel comfortable using it for any indication for which the innovator drug has existing FDA approval,” says Philip E. Lammers, MD, MSCI, assistant professor of medicine and chief of the Division of Hematology/Oncology at Meharry Medical College.

For example, he says that “bevacizumab biosimilars may show clinical efficacy that is highly similar to the innovator drug in first-line treatment of metastatic non-squamous non–small cell lung cancer. If the biosimilar is approved, it will be potentially available to use in metastatic colorectal cancer and kidney cancer, two other indications for which the innovator drug has FDA approval.”

DT: Will community pharmacists have to deal with cancer biosimilars?

A: Not now-and perhaps not for some time. Most will be administered in infusion centers, says McBride at the University of Arizona Cancer Center.

 

But Mary Jo Carden, RPh, JD, vice president of government and pharmacy affairs with the Academy of Managed Care Pharmacy, says many commonly used biologics for cancer and other conditions are self-administered, raising the prospect that community pharmacists will be seeing more biosimilar medications.

McBride predicts that community pharmacists will face special challenges on the legal front as biosimilar drugs become more common. According to him, they’ll need to navigate a variety of laws about whether biosimilars can be interchanged with biologics without a physician’s approval.

About 20 states now allow pharmacists to substitute biosimilars in some cases.

DT: How can pharmacists best educate patients about cancer biosimilars?

A: It’s important to make it clear that biosimilars aren’t generics. “The simplest way to explain the difference between generic drugs and biosimilars is to help patients understand that biologics are complex protein-like chemicals made by living cells,” says Ronald P. Jordan, RPh, FAPhA, dean of the Chapman University School of Pharmacy. “Generic drugs are usually small-molecule chemicals synthesized in a test tube.”

The structures of biologics can vary, Jordan says, “but usually these variations will not be noticeable.”

DT: What will happen on the cost front?

A: It’s not clear. Estimates suggest that biosimilars could be 20% to 30% less expensive than the original biologics. A 2014 report from Rand Corporation estimates that “biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, or about 4% of total biologic spending over the same period, with a range of $13 billion to $66 billion.”

 

The report cautions that the actual savings will depend on factors such as FDA regulations, competition, and openness to biosimilars among patients, physicians, and payers.

Scarpace, who serves as president of the Hematology/Oncology Pharmacy Association, says the savings will have special meaning in the world of cancer treatments. “Many, including Vice President Biden, have commented on the very unusual phenomenon that we have seen in cancer care-that drugs that have been on the market for years seem to increase in price each year, which is completely contrary to most other commodities,” she says.

For now, though, the savings from biosimilars for cancer-and the benefit-remain to be seen.

Disclosures: Carden has no relevant disclosures. Jordan is a volunteer adviser to the Safe Biologics Organization. Dr. Lammers has received honoraria from Pfizer for participating in advisory boards. Dr. McBride has been on the advisory boards for Sandoz and Hospira. Dr. Scarpace is on speakers bureaus for Eli Lilly, Merck, Pfizer, and Boehringer Ingelheim.

Randy Dotingais a medical writer based in San Diego.