BOSTON (FRONTLINE MEDICAL NEWS) – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.

“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg , at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.

Mr. Ginsberg should know: he was diagnosed with spondyloarthritis at the 13 years of age, and at age18 cofounded the online community for patients with arthritis. The availability of biologic agents to patients with rheumatic diseases cannot be overemphasized, Mr. Ginsberg said.

He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.

“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.

Biosimilar confidence

His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.

The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.

“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.

Patient concerns

Surveys of patient concerns about biosimilars have highlighted four key areas:

The implementation strategy for the campaign will focus on speaking directly to patients through, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.

“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.

Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”

“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars . Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.

Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.

“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.


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