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Biocon Biologics Ltd. announced today the FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara (ustekinumab) biosimilar, for the treatment of patients with inflammatory bowel disease, plaque psoriasis and psoriatic arthritis, according to the details of a 

 no later than Feb. 22, 2025 in the United States.

 which are artificial proteins that are meant to stimulate the immune system, according to the National Cancer Institute.

Launch date is based on a licensing agreement between Biocon Biologics, Janssen Sciences Ireland and Johnson & Johnson. Although the patents for ustekinumab began expiring in 2023, licensing agreements prevent its biosimilars from being released in the United States until next year. 

Stelara was originally approved by the FDA in September 2009 for the treatment of adults with moderate to severe psoriasis.

In addition to Yesintek, the other Stelara biosimilars are:

Imuldosa (ustekinumab-srlf) approved in Oct. 2024

Otulfi (ustekinumab-aauz) approved in Sept. 2024

Pyzchiva (ustekinumab-ttwe) approved in June 2024

Selarsdi (ustekinumab-aekn) approved in April 2024

Wezlana (ustekinumab-auub) approved in Oct. 2023

Stelara, developed by Janssen, a Johnson & Johnson company, is a high-cost drug with a list price of $13,836 for one month’s supply. It generated $10.86 billion in revenue globally in 2023 compared with $6.4 billion the previous year. Stelara is available for $5 a dose for eligible patients through the savings program 

Stelara is one of the drugs soon to be discounted under the Inflation Reduction Act. Starting in 2026, Medicare members will be able to get a 30-day supply for 66% off list price, costing $4,695.

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

Formulary Watch

Clinical

Sixth Stelara Biosimilar, Yesintek, Approved by FDA

UnitedHealthcare CEO Brian Thompson was shot and killed this morning in front of the New York Hilton Midtown in Manhattan by a masked man, according to news reports.

During a live press conference broadcasted by the 

 this morning, NYPD Chief of Detectives, Joseph Kenny, stated in a preliminary report a 911 call was made at 6:46 a.m. for a person shot in front of the hotel.

Thompson, 50, was identified as the victim of the targeted attack by the gunman who fled the scene and is still at large.

Police are currently unaware of the motive. 

Thompson was taken to Mount Sinai Hospital and was later pronounced dead.

Chief Kenny shared that the gunman, who appears to be a light-skinned male, arrived at the location of the shooting on foot roughly 5 minutes prior to Thompson's arrival. The gunman stood alongside the building as numerous pedestrian's passed.

Based off of camera footage, Chief Kenny described Thompson leaving his hotel across the street from the Hilton at 6:44 a.m. The gunman then approached Thompson from behind and fired several shots. 

After the shooting, the gunman fled on foot into a nearby alleyway eventually riding an electric Citi Bike into Central Park at 6:48 a.m.

A cellphone was recovered near the scene and is being investigated to see if it's connected to the incident, police report.

Prior to the tragic moment, Thompson was on his way to attend an annual investor conference being held at the hotel.

UnitedHealthcare, the health insurance division of UnitedHealth Group, is one of the nation’s largest health insurers. Thompson has been with the company for more than 20 years, according to his LinkedIn profile. He was appointed as CEO of UnitedHealthcare in April 2021.

UnitedHealth Group later issued a statement on the situation. 

“We are deeply saddened and shocked at the passing of our dear friend and colleague Brian Thompson, the CEO of UnitedHealthcare. Brian was a highly respected colleague and friend to all who worked with him. We are working closely with the New York Police Department and ask for your patience and understanding during this difficult time. Our hearts go out to Brian’s family and all who were close to him.”

NYPD Commissioner, Jessica Tisch encouraged the public to come forward with any information supporting the case, noting a $10,000 reward is being offered.

Tisch also advised that all members of the NYPD will be taking firm action in the safety of visitors safe at tonight's annual tree lighting ceremony at the Rockefeller Center. The Rockefeller Center is only a few blocks away from this morning's incident. 

Thompson, who was on his way to attend an annual investor conference in Manhattan today, was shot after 6:45 a.m. in a targeted attack, police officials say.

UnitedHealthcare CEO Brian Thompson Shot, Killed

In July 2022, Amanda Butler found a lump in her right breast during a self-exam, which she did monthly. At the time, she didn’t have a gynecologist, but in a moment of what she calls “divine intervention” she ran into a friend of a friend in the bathroom at a wedding. This friend happened to be a gynecologist.

“I was like, ‘I know we literally just met two seconds ago, but I found this lump, and I don't have a gynecologist, could you do a breast exam on me?” Butler said in an interview with Managed Healthcare Executive.

Her now mutual friend gladly obliged and afterward advised Butler to get an ultrasound. This ultrasound led to a few biopsies, all the while the office staff reassured her that the lump was “probably nothing” because she was “so young.”

It was not nothing. It was breast cancer. She was BRACA 2+ and it had already spread to Butler’s lymph nodes. 

“Breast cancer is lifelong because this is something I’ll have to think about for the rest of my life,” Butler said. “It’s always in the back of my mind.”

Butler, then 32, had a double mastectomy with breast reconstruction.

Rather than just getting a single mastectomy, Butler opted for a double to eliminate risk for resurgence. Within a month, she froze her eggs and began chemo in November 2022. She is now cancer free and awaiting her second round of breast reconstruction surgery.

“I feel like I'm still in it, you know?” Butler said. “I don’t think I’ve fully processed this emotionally.”

Breast cancer is currently the most common cancer for women in the United States, accounting for about 

 of all female cancers every year. The American Cancer Society estimates there will be about 310,720 new cases this year, resulting in around 42,250 deaths.

Previous mammogram guidelines from The U.S. Preventive Services Task Force recommended that women start getting mammograms at age 50 every year or every other year. As of April 2024, the USPSTF urges women to begin mammogram checks every other year staring at age 40.

Early detection is especially important because breast cancer in women younger than 40 also tends to be more aggressive.

Butler, now 34, is one of a growing number of women under age 40 in the U.S. diagnosed with breast cancer.

For example, women born in 1990 had a 20% greater risk of developing breast cancer than women born in 1955, according to 

While active cancer is a huge battle in and of itself, and although survival rates have increased, 

 of survivors experience lasting physical and emotional challenges, a 

Journal of Midwifery and Women’s Health

As part of her breast reconstruction, Butler had to get expanders placed in her chest where they stayed for about a year. Expanders function as a placeholder for breast implants and are gradually filled with saline until they react the desired cup size.

Butler said while expanders were hard and uncomfortable, she only had one minor infection in the beginning. Once the expanders were taken out, the implants were put in. Her surgeon also did a fat transfer that filled in the area around the implant to make her breasts look natural. Numerous adjustment surgeries often follow because over time, the fat is reabsorbed by the body, which causes rippling and divots around the implant.

Butler has a popular TikTok account where she speaks openly about her experience with breast cancer, documenting everything from being in a hospital bed with a mask and surgical cap on to showing the ways the fat transfers have changed her body.

“People who aren’t in this are just like ‘oh, you’re getting a free boob job,’” Butler said. “That’s what I thought, too. Then then you go through it and realize it’s not a boob job, it’s an amputation.”

Katelyn Armstrong has also documented her breast cancer journey on her TikTok page, sometimes appearing shirtless to bring awareness to double mastectomies and shed light on the difficulties of life in remission.

Armstrong discovered her breast lump during a shower but thought nothing of it because she knew she had dense breast tissue. About two weeks later, the lump became painful. After s doctor’s appointment, so began the avalanche of mammograms, ultrasounds and biopsies.

The lump was first felt in October 2022. By December, she was diagnosed with triple positive breast cancer. She has been cancer-free since March 2023.

Armstrong had a double mastectomy in May 2022 at 35 years old. She chose a flat closure instead of a breast reconstruction.

“Nobody really talks about the emotional recovery of it,” Armstrong said in an interview. “You get a lot of, ‘oh, you're good now?’ questions when you finish treatment. The emotional recovery and physical effects of treatment that you deal with on an ongoing basis is lengthy. Sometimes it's forever.”

Because Armstrong’s breast cancer was hormone positive, she will be on a hormone suppressant medication for the rest of her life. Hormone suppressants turn off all the hormones in the body so that cancer doesn’t have anything to “feed” on if it comes back. As a result of hormone suppression, Armstrong has gone into early menopause.

“Couple that with the PTSD that you experience from your body basically betraying you…there is no guidance when you’re ‘done’ with medical stuff,” Armstrong said.

October is Breast Cancer Awareness month and for some survivors, it’s a double-edged sword. 

“October can be really a difficult time of the year for people in the breast cancer community,” Armstrong said. “As much as we’re so appreciative of the awareness, you're being assaulted by your perpetrator every day, for days. You can't even go to the grocery store without seeing pink ribbons on bananas.”

Both Butler and Armstrong shared ways to make this month easier on survivors and said it all starts with intention.

“I do think that there are issues with mass corporations using this as a way to raise money for themselves. Breast cancer is an easy way to do it because a lot of people have been touched by it,” Butler said.

Armstrong agreed and added it’s important to know where the proceeds are going and how much of them are going towards the cause. “At the end of the day, I think what it's become, is a business. Of course, the intentions are there, but you can have good intentions and still need to improve your method.”

“I think tapping into real survivors,” Butler said. “If you're going to help people with cancer, then it needs to 

The effects of breast cancer can remain long after the disease has left the body, serving as a traumatic daily reminder.

Why Cancer Doesn’t Stop After Chemo, Survivors Speak Out 

Drugs to treat diabetes have been the focus of many efforts to bring down costs for both patients and payer. It’s not heard to see why.  More than 38 million people are diagnosed with diabetes in the United States, and treatment costs  continue to rise.  People with diabetes now account for one of every four healthcare dollars spent, according to a 

CVS Caremark has removed several diabetes drugs  favor of newer products and generics, and is even favoring an insulin infusion system developed by a company that was cofounded by Alan Lotvin, a former executive at CVS Health.


Olivia J. Phung, PharmD

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