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In what may usher in a new era of competition on price among insulin products, FDA has approved the first interchangeable biosimilar insulin product.

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product, Sanofi’s Lantus (insulin glargine), according to the FDA approval yesterday. Being interchangeble means that Semglee doesn’t need to be explicitly prescribed and can be substituted for Lantus by a pharmacist who is filling the prescription.\

The FDA has approved 29 biosimilars but Semglee is the first that wasapproved as being interchangeable with its brand-name reference product.

The FDA approved Semglee last year and it has been on the market since but interchangeable designation is likely to increase its use and is intended to stir up vigorous price competition between Semglee and Lantus.

Theinterchangeabilityapproval was announced yesterday in a press release by the FDA. Biocon Biologics developed Semglee and Biocon’s distribution partner is Viatris, a company that is the result of a merger between Mylan and Upjohn.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D., in the 

The approval “furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock added.

Biosimilars in the U.S. typically have launched with initial list prices that are 15% to 35% lower than the list prices of the reference products, FDA said.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, M.S., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber, FDA explained. The substitution may occur at the pharmacy — “pharmacy-level substitution”—much like generic small-molecule drugs are now substituted for brand-name drugs, although there is state-to-state variability because state-level pharmacy laws apply to interchangeability. In most states, patients will need to be told they are getting an interchangeable biosimilar and pharmacists will not be allowed to make the switch if the prescribing physician have expressly indicated they are prescribing the reference product (in this case, Lantus).

The approval of Semglee as an interchangeable biosimilar to Lantus is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between them.

Research has shown that Semgleecan be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee and Lantus (insulin glargine) is not greater than the risk of using Lantus without such switching, the FDA said.B

 for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

Articles

FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.

An FDA First: Semglee Is Approved As An Interchangeable Biosimilar

A new analysis bodes well for AbbVie’s Humira (adalimumab) profits, as it vigorously attempts to fend off competition from biosimilar competitors to one of the leading treatments for rheumatoid arthritis and other autoimmune diseases.

In fact, AbbVie has battled new biosimilar competitions so aggressively, that a recent 

 from the House Committee on Oversight and Reform describes a “cold and heartless” methodology to keep competitors away from its franchise, according to 

The scathing congressional report says that AbbVie has raised the price of Humira 27 times. A 40mg/mL syringe is now priced at $2,984 — $77,586 annually — which works out to be a 470% increase in price from when the drug launched in 2003. 

Humira has netted AbbVie $170 billion in net revenue worldwide since 2003, “Including $107 billion from the U.S. health care system,” according to the congressional report.

Humira prices in the European Union, where the drug has biosimilar competition, are often less than half or one-third the cost than prices in the US.

The congressional report also alleges that there is an unspoken collaboration between AbbVie and Amgen, which markets Enbrel (etanercept), a brand-name competitor to Humira. 

“Instead of pricing Humira and Enbrel below one another to gain market share — as expected in a competitive market — AbbVie and Amgen engaged in a practice known as 'shadow pricing,' consistently following the other company’s price increases,” the report says.

Currently, there an't any biosimilars to Humira on the market in the U.S., although six have been approved by the FDA and may come on the market in 2023. However, Alvotech, an Icelandic biosimilars company, believes it has obtained the data it needs to convince the FDA to award an “interchangeable” designation for its high-concentration, citrate-free biosimilar candidate (AVT02), to Humira per 

Although AbbVie is working to stave off biosimilar competition, the threat to its revenues from Humira revenue may be less than expected, at least in the initial period of biosimilar competition, SVB Leerink Analyst Geoffrey Porges and his team wrote in a new research note obtained by 

“Our analysis suggests that US Humira could experience a more gradual revenue decline than our current estimate of 71% erosion within 11 quarters,” Porges wrote. “While we expect Humira to have a steeper revenue erosion in the U.S. than Remicade, we believe the branded drug has some unique formulation characteristics (broader dose range and reduced injection site pain) and a broad label centered on disease indications that require chronic treatment, that could defend its franchise from rapid erosion.”

Fiscal year 2023 revenue in the US could still be $17.9 billion at the median and $14.5 billion at the minimum — higher than consensus and the firm’s current estimate, the analysts noted.

“Our analysis suggests that Humira could experience a more gradual revenue erosion in 2023 and 2024, which leaves substantial upside for AbbVie’s revenue outlook during this transition period,” Porges wrote.

Research note from SVB Leerink says revenue erosion once biosimilars hit the market in 2023 may be more gradual than some prior predictions.

When Humira Finally Faces Biosimilar Competition, Losses For AbbVie May Not Be As Steep As Expected, Say Analysts

The Pfizer COVID-19 vaccine confers low immunity on people with advanced liver disease, so a third booster shot may be needed, according to a research presented at the 

 in Geneva, Switzerland, which was held from June 23-26.

, professor of medicine at the Hadassah-Hebrew University Hospital in Israel, presented the study at the meeting convened by the European Association for the Study of the Liver (EASL).

Older age and advanced liver disease are risk factors for a lower immune response to the Pfizer’s COVID-19 vaccine, Safadi reported, according to a 

Safadi and researchers analyzed 88 patients living with hepatic fibrosis who had received both doses of the Pfizer vaccine to assess their immune response. He found that older age and advanced fibrosis with decreased steatosis are risk factors for less robust immune response to the vaccine.

Safadi suggested that a third dose of the vaccine booster should be evaluated in populations with lower immune response, according to the statement.

“We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at (the International Liver Congress meeting) will advance our knowledge on multiple fronts — knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philipp Newsome, general secretary of EASL and professor of experimental hepatology and director of the Centre for Liver Research at the University of Birmingham in the United Kingdom.

Other findings related to COVID-19 that were presented at the 2021 include:

Chronic liver disease increased the odds of COVID-19 death by 80%, according to French researchers. Overall, 8.7% patients diagnosed with chronic liver disease were admitted for COVID-19 in France in 2020 and 24.1% of them died, most (63.9%) after a liver-related complication, according to researchers at 

The researchers compared patients with chronic hepatitis B on the antiviral drug treatment tenofovir for Baraclude (entecavir) and found that although the incidence of COVID-19 in patients taking the medications was similar, patients taking Baraclude were more likely to have a severe case of COVID-19. Tenofovir reduced the risk of severe COVID-19 by sixfold, the researchers said. “TDF(tenofovir) seems to exert a protective effect in patients with CHB infected by COVID-19,” according to the press release.

Third COVID-19 Jab May Be Needed for Patients With Advanced Liver Disease

A unique smartphone-based electrocardiogram (ECG) screening accurately detected previously unknown atrial fibrillation in Native Americans and in doing so might have prevented ischemic strokes.

The technology study, detailed in a recent 

 article, is just one example of how smartphones are being utilized more often in every aspect of healthcare, from clinical research studies to patient care. Researchers at Memorial Sloan Kettering Cancer Center in New York City are also in the process of testing the effectiveness of mobile technology intervention on breast cancer patients' self-management of the oral anticancer medication Ibrance (palbociclib).

Self-management Being Put to the Test in MSK Study of Patients Taking Ibrance

In this study of Native American, more than 1,000 participants underwent a 30-second, single-lead ECG using the mobile device paired with a tablet or smartphone at a tribal clinic. Then researchers compared the ECG results of the screened participants to the results of a control group who did not receive the mobile-based ECG screening.

The researchers discovered atrial fibrillation in 1.5% of patients in the smartphone ECG program versus 0.3% of patients in the control group.

Of the patients diagnosed with atrial fibrillation, 14 had a high risk of stroke, as measured by the 

 score (the standard measure to calculate stroke risk) and met the criteria for initiation of blood-thinning medication.

Notably, around half of those diagnosed with atrial fibrillation by mobile-based ECG were younger than the recommended screening age of 65 years old.

The findings are important because about one-third of ischemic strokes, are caused by atrial fibrillation, the most common heart rhythm disorder, the American Heart Association said in a 

. “Since many people don’t have symptoms and are unaware of its presence, atrial fibrillation often goes undiagnosed. In some cases, a stroke is the first sign that a person has the disorder,” AHA said.

Moreover, Native Americans are more at risk for atrial fibrillation than people in other racial and ethnic groups. “As a population, American Indians also have substantially higher rates of obesity, diabetes and high blood pressure — all risk factors for atrial fibrillation,” noted the AHA press release.

“Systemic screening among American Indians has never been done before, and the true rate of atrial fibrillation in this population is unknown," said lead study author Stavros Stavrakis, M.D., Ph.D., a cardiologist at the Heart Rhythm Institute of the University of Oklahoma Health Sciences Center and associate professor of medicine at the University of Oklahoma College of Medicine in Oklahoma City.

“Our study shows that we have a very simple and accurate method to screen and diagnose atrial fibrillation that is easy to implement at tribal clinics. This widely-available, low-cost approach has real potential to improve health outcomes among American Indians,” Stavrakis added.

American Indians develop cardiovascular diseases at earlier ages than the national average, AHA said, and more than one-third of deaths attributed to cardiovascular disease in American Indians occur before 65 years old.

“In a targeted, high-risk population such as American Indians, our results showed screening at a younger age found many cases of atrial fibrillation that would have been missed following current age recommendations,” Stavrakis said. “We have the potential to improve outcomes in this population by initiating early treatment.”

The study was funded by the National Institute of Minority Health and Health Disparities of the National Institutes of Health.

Program could be easily implemented at tribal clinics, says lead author.

Christine Blank

Articles

An FDA First: Semglee Is Approved As An Interchangeable Biosimilar

When Humira Finally Faces Biosimilar Competition, Losses For AbbVie May Not Be As Steep As Expected, Say Analysts

Third COVID-19 Jab May Be Needed for Patients With Advanced Liver Disease

Novel Smartphone Screening Program Detects Atrial Fibrillation in Native Americans