Why Is Stelara So Expensive – A Phase 3 study conducted by Amgen found that the company’s ustekinumab biosimilar was as safe and effective as the reference product (Stelara) in patients with moderate to severe plaque psoriasis.

Amgen shared preliminary results from its Phase 3 study showing that the company’s ustekinumab biosimilar (ABP 654) has comparable safety and efficacy profiles to the reference product (Stelara) in patients with plaque psoriasis.

Why Is Stelara So Expensive

A multicenter, randomized, double-blind, comparative clinical study met the primary efficacy endpoint showing no clinically meaningful differences for the biosimilar candidate compared to Stelara.

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“Amgen is committed to providing high-quality biosimilar medicines to patients living with inflammatory diseases. We look forward to continuing to expand our inflammation portfolio to provide patients with a variety of treatment options,” said David M. Reese, executive vice president of research and development at Amgen, in a company announcement.

About 125 million people worldwide have psoriasis, including about 14 million in Europe and more than 7.5 million in the United States. About 80% of people with psoriasis have plaque psoriasis.

Stelara, a drug developed by Janssen, is an interleukin-12 and interleukin-23 antagonist used to treat moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Ustekinumab products can also be used to treat adults with active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis.

According to Janssen’s annual report, Stelara will generate approximately $5.9 billion in US sales in fiscal 2021. The latest patent expires in September 2023. There are currently no ustekinumab biosimilars approved in the United States or the European Union.

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The analysis assessed the percentage change in Psoriasis Area Severity Index in adult patients with moderate and severe plaque psoriasis over 12 weeks. In total, 563 patients were randomized to receive the biosimilar (n = 281) or the reference product (n = 282).

In addition to Amgen, Pharmacon, Samsung Biopis, Bio-Thera Solutions, Hikma Pharmaceuticals, Alvotech, Biofactura and Nucleon are in the process of developing their own biosimilars to Stelara.

Pharmacon recently acquired the assets for the ustekinumab biosimilar and the biosimilar referencing Lucentis (ranibizumab) from ATHOS. Formycon retains full commercialization, development and approval rights to the ustekinumab candidate.

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Bio-Thera and Hikma have partnered to commercialize BAT2206, with Hikma holding commercial rights for the United States and negotiating rights for commercialization in Europe. Bio-Thera has announced the initiation of a Phase 3 trial for its ustekinumab biosimilar in July 2021.

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In July 2021, Samsung Bioepis began a Phase 3 trial for another potential Stelara rival, SB17. If the candidate is approved by the FDA, physicians in the United States may extrapolate its use for other indications approved for the reference product.

That same month, BioFactura announced the start of its Phase 1 trial for its biosimilar candidate (BFI-751). In September 2021, the company partnered with Maryland-based Rani Therapeutics to develop a robotic pill that could be packaged and injected into the small intestine.

Alvotech announced the start of clinical evaluation of its potential biosimilar (AVT04) in July 2021, saying it has begun recruiting patients with plaque psoriasis from Central and Eastern Europe, New Zealand and Australia for 2 studies evaluating the biosimilar’s safety, efficacy, and efficacy. and pharmacokinetics.

In October 2020, Nucleon shared positive results from its Phase 1 trial evaluating pharmacokinetic similarity between its candidate (Neulara) and samples of Stelara from the United States and the European Union. The company has confirmed that the biosimilar is comparable to the reference product in safety, immunogenicity and tolerability in healthy individuals.

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A June 28, 2023 article by the Center for Biosimilars® provides an updated look at the adalimumab biosimilars coming in the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

In the April 30, 2023 episode of the Not So Different podcast, we recap some of April’s top news regarding biosimilars used to treat rheumatic conditions, including some progress and some setbacks, as well as research on non-medical conversions from sources to biosimilars.

June 17, 2023 Article Coherus Biosciences and AbbVie agree to settle dispute over Coherus’ partnership with Mark Cuban cost plus drug company and adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expand their partnership to include more biosimilar products.

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April 16, 2023 Podcast What can practices do to prepare for all the biosimilars for rheumatoid arthritis (RA) treatment coming down the pipeline? And how can they ensure that lower-than-expected adoption rates for infliximab biosimilars do not recur? Robert Jutat, RPh, from McKesson Provider Solutions, tackles all of this and more in this episode of Not So Different.

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June 13, 2023 Article A survey of patients with rheumatoid arthritis who switched to an adalimumab biosimilar reported higher disease severity, poorer treatment adherence and poorer quality of life compared with patients on the reference product. Nocebo effect.

June 12, 2023 Article Infliximab (IFX) biosimilar SB2 has been shown to be safe and effective in IFX-naïve patients and those switching from a previous IFX reference or biosimilar. President Joe Biden speaks in Florida, emphasizing how the midterms will affect the future. Prescription prices, Social Security and Medicare.

As pharmaceutical companies hiked prices on nearly 1,000 drugs in January, some consumers could face sticker shock the next time they pick up prescriptions.

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The new federal law requires companies to pay a rebate to Medicare if they raise prices above the rate of inflation. Other inflation-reducing law provisions — such as capping Medicare recipients’ out-of-pocket costs at $2,000 and allowing Medicare to negotiate the most expensive drugs — have not yet been enacted.

Major drug companies such as AbbVie, Pfizer and Bristol-Myers Squibb have raised prices so far this month, according to data provided by 46Brooklyn Research, a nonprofit that researches drug prices. The amount consumers pay depends on their insurance coverage and complex discounts. Public view.

Drug affordability remains a major concern for consumers. According to a Kaiser Family Foundation poll last year, 3 in 10 people don’t take their medications as prescribed because of the cost–some don’t fill prescriptions, others skip doses or seek cheaper over-the-counter drugs.

Analysts say it’s too early to tell if this month’s rate hikes were influenced by the federal law. But drugmakers often launch new drugs at higher prices and try to boost sales before Medicare bargains for more affordable prices, experts say.

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“Each year it becomes more difficult to raise prices,” said Dr. Benjamin Rome, professor of medicine at Harvard Medical School. “You’re going to see changes in price behavior over the lifecycle of drugs based on the law of inflation.”

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Drug companies often raise prices for existing drugs in January, but the amount of price increases varies from year to year.

46Data from Brooklyn lists drug prices but does not include discounts and rebates for insurance companies or pharmacy benefit managers. Such subsidies are becoming more expensive every year and do not always result in lower prices for consumers.

Drug manufacturers who raise prices above inflation levels must pay rebates to Medicare. The law applies this year to retail and physician-administered drug prices.

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Although inflation is retreating from four-decade highs reached last summer, it is well above the small rates that preceded the COVID-19 pandemic. So some drug companies may see an opportunity to increase retail drug prices to the rate of inflation.

“Inflation is running higher than recent historical trends,” said Ryan Urgo, managing director of health policy at Avalere, a health care consulting company.

Medicare tries to control the prices of the most expensive drugs by negotiating directly with manufacturers. As of September 1, the federal health program will select the first 10 drugs to negotiate maximum prices that will take effect in 2026.

The federal health program negotiates more retail “Part D” drugs and physician-administered “Part B” drugs, but drug makers get several years of pricing autonomy before the drugs are subject to negotiations. Part D drugs become eligible only after they are on the market. Nine years. Physician-administered medications are 13 years subject to negotiation.

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Federal law does not limit the amount manufacturers can charge for new drugs once they start selling them after receiving Food and Drug Administration approval.

A study found that generic launch prices for new drugs have risen 20% each year over the past decade and a half, putting the total U.S. spending on prescription drugs at more than $500 billion in 2020. Contributed to the cost.

About half of new drugs in 2020 and 2021 will cost $150,000 a year. Less than 10% of new drugs launched at that price in 2008, according to a study co-authored by Harvard Rome last year.

Because Medicare is capped annually

Part 2: For Patients And Employers, 2023 Means A Changed Landscape

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