Biosimilar drugs gain ground, but concerns linger about switching – Boston, Massachusetts

Boston, Massachusetts 2021-09-21 04:45:29 –

MeIt took El Moxley years to be diagnosed to explain her devastating gastrointestinal pain and digestive problems, malaise, and a hot, red rash.But even after learning what she had in 2016 Crohn’s diseaseA chronic inflammation of the digestive tract, she took more than four years to try different drugs before she could control her illness with a biological drug called Remicade.

As a result, 33-year-old Moxley was disappointed in January when he received a notice from the insurance company that Remicade would no longer be covered as a priority drug in her plan. Another drug, infliximab, which the Food and Drug Administration says is not significantly clinically different from Remicade, is currently preferred. It is a “biosimilar” drug.

“I felt very helpless,” said Moxley, who recently started working as a public relations coordinator for Kansas City Public School in Missouri. “This decision was made for me and my doctor, but it is not in my best interests. It may take me out of remission.”


After Moxley’s first infliximab injection in July, she developed a painful rash. It disappeared after a few days, but she said she continued to feel very tired and experienced gastrointestinal pain, constipation, diarrhea, and nausea.

Many healthcare professionals are looking at biosimilars as a way to intensify competition and provide consumers with as cheap an option as generics, and to reduce costs with these products in Europe. It points out that it will be used more strongly. However, biosimilar uptake is generally slow in the United States since the first such drug was approved in 2015. This is partly due to concerns from patients such as Moxley and his doctors, but also due to the success of branded biologics. Prevented biosimilars from entering the marketThrough a combination of legal action to extend the life of a patent and incentives that make it more attractive to offer brand-name biopharmacy on prescription drug lists than biosimilars.


Jinoos Yazdanny, a professor of medicine at Zuckerberg San Francisco General Hospital and head of the rheumatism department, said:

The FDA has approved 30 biosimilars since 2015, NORC, a research institute at the University of Chicago..

Johnson & Johnson, the manufacturer of Remicade, and Pfizer, which turns Remicade into biosimilar infliximab, try to prevent Johnson & Johnson from competing through exclusive contracts with insurance companies and other anti-competitive behavior. He has been involved in a long-term lawsuit over Pfizer’s allegations that he did. In July, the two companies settled the proceedings on private terms.

Pfizer said in a statement that it would continue to sell Inflectra in the United States, but said of the ongoing challenges: “Pfizer has begun to make progress across the US biosimilar market. Stakeholders are critical to achieving more meaningful uptake, so patients and the entire healthcare system will benefit from these medicines. You can benefit from potential cost savings. “

Johnson & Johnson said it promised to make Remicade available to patients of choice. This “needs to compete responsibly in both price and value.”

Biological drugs such as Remicade, which generally grow from organisms such as animal cells and bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biological agents have become central to the treatment of autoimmune diseases such as Crohn’s disease and rheumatoid arthritis, as well as certain cancers, diabetes and other diseases.

Other pharmaceutical companies cannot accurately reproduce these biological drugs according to chemical recipes, as they do with generic versions of traditional drugs.

Instead, Biosimilar version Bioforms are usually made from the same type of material as the original bioform and must be “very similar” to them in order to be approved by the FDA. They cannot make a clinically meaningful difference from biological agents and must be just as safe, pure and powerful. More than a decade ago, Congress created approval channels for biosimilars, and they are widely accepted as safe and effective alternatives to branded biologics.

Medical professionals want biosimilars to increasingly put a brake on drug spending as they become more widely used.

Between 2015 and 2019, overall drug spending increased by 6.1% and biopharmaceutical spending more than doubled (14.6%), according to a report from healthcare analytics firm IQVIA. In 2019, biopharmaceuticals accounted for 43% of US drug spending.

Biosimilars offer about 30% discounts compared to US brand biologics, but IQVIA analysis found that they could save more than $ 100 billion over the next five years.

In a survey of 602 doctors prescribing biopharmaceuticals, More than three quarters According to NORC, they believe that biosimilars are as safe and effective as biopharmacy.

However, they were not very accustomed to switching patients from brand-name biopharmacy to biosimilars. About half said they were very likely to prescribe biosimilars to patients who had just started biotherapy, but biosimilars to patients who were already successful with branded biopharmacy. Only 31% said they were very likely to prescribe a mirror.

Finding an effective treatment for patients with complex chronic illnesses can be difficult, and doctors and patients often do not want to rock the boat once it is achieved.

For example, in the case of Moxley, she tried a traditional pill called, before the condition stabilized with Remicade. Rialda, Biological drug Fumira, and low dose Remicade.

Some doctors and patients have expressed concern that switching between these drugs could cause them to develop antibodies and lose their effectiveness. They would like to see more research on the effects of such switches.

Marcus Snow, MD, Physician and Chairman of the American College of Rheumatology’s Rheumatology Treatment Committee, said: “We don’t want patients to be guinea pigs.”

However Research shows Ross Marz, a pediatric gastroenterologist at the National Children’s Hospital in Columbus, Ohio and a former member of the National Scientific of Crohn’s & Colitis Foundation, said a one-time switch from Remicade to a biosimilar like infliximab is a side effect. And did not cause the development of antibodies. Advisory Committee. Research is conducted by researchers with a wide range of industry relationships and may be funded by pharmaceutical companies.

Kristine Grow, senior vice president of communications for insurance industry group AHIP, said situations like Moxley are rare.

“For patients who have been taking brand-name biopharmacy for some time, health insurance companies usually do not recommend switching to biosimilars due to changes in their prescription drug list. Most plans We exclude these patients from changing the cost sharing of prescription drug lists. They will change, “she said.

Pharmaceutical companies can ask the FDA for biosimilar approval. Exchangeable Biological medicines allow pharmacists subject to state law to switch their doctor’s prescriptions from branded medicines, as is often the case with generics.

However, the FDA has approved only one biosimilar (Semglee, a type of insulin) that is compatible with the biopharmacy drug Lantus.

Many other patients using biologics, such as Moxley, receive out-of-pocket assistance from pharmaceutical companies, but often the money is not enough to cover the full cost. In her old job as a radio reporter, Moxley said she reached a maximum annual out-of-pocket spending limit of $ 7,000 for her plans in May.

In her new job, Moxley has a personalized plan with an out-of-pocket limit of up to $ 4,000 and expects it to be blown away again within a few months.

But she recently received good news: her new plan will cover Remicade.

“I’m worried that antibodies will be developed since the last dose,” she said. “But it feels like a step towards good health again.”

KHN (Kaiser Health News) is a national news room that produces detailed journalism on health issues. KHN, along with policy analysis and polling, is one of three major operational programs: KFF (Kaiser Family Foundation). KFF is a donated non-profit organization that provides the public with information on health issues.

Biosimilar drugs gain ground, but concerns linger about switching Source link Biosimilar drugs gain ground, but concerns linger about switching

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