Connect with us

FDA CDC News

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

Published

on

Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: 

Adult patients with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
  • active psoriatic arthritis;
  • moderately to severely active Crohn’s disease; and
  • moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
  • active psoriatic arthritis.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs. 

All biological products are approved only after they meet the FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Advertisement

Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.

The labeling for Wezlana, like Stelara, contains a warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome  have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

The FDA granted the approval of Wezlana to Amgen, Inc.

Related Information

Author


Discover more from Daily News

Subscribe to get the latest posts sent to your email.

FDA CDC News

Important Recall Alert – Listeria Contamination in Meal Kits

Published

on

mouthwatering tacos in macro shot photography. Listeria
Photo by Jeswin Thomas on Pexels.com

In recent news, Reser’s Fine Foods has issued a recall on several of its popular meal kits due to potential contamination with Listeria monocytogenes, a harmful bacteria known to cause food poisoning. This recall was prompted by the inclusion of chicken from their ingredient supplier, BrucePac, which has also been recalled due to contamination concerns.

What Products Are Affected?

The affected meal kits include a variety of delicious options that many consumers may have purchased. These products consist of:

  • Taco Meal Kits
  • Enchilada Meal Kits
  • Quesadilla Meal Kits
  • Stir Fry Meal Kits
  • Salad Meal Kits

All of these products have been classified under a Class II recall by the U.S. Food and Drug Administration (FDA), indicating that while exposure may lead to temporary or medically reversible health consequences, the probability of serious adverse health effects is remote.

Understanding Listeria

Listeria monocytogenes is a bacterium that can lead to listeriosis, a serious infection typically caused by eating contaminated food. Symptoms can include fever, muscle aches, and gastrointestinal issues. Pregnant women, newborns, older adults, and individuals with weakened immune systems are particularly vulnerable to severe outcomes from listeriosis.

What Should Consumers Do?

If you have purchased any of the affected meal kits, it is crucial to check the packaging for any recall notices. Consumers should discard any recalled products or return them to the place of purchase for a refund. It is also advisable to stay informed by checking official announcements from the FDA and Reser’s Fine Foods regarding the recall.

Stay Informed

For the latest updates and more detailed information about this recall, visit the following resources:

Stay vigilant and prioritize your health by being aware of food recalls and potential safety issues. Your safety is paramount, so always make sure to stay informed about the food products you consume.

Related link:

https://www.newsweek.com/taco-meal-kit-recall-30-states-fda-1978552

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Advertisement

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

https://stmdailynews.com/food-and-drink/

HUNGRY FOR MORE?

Discover a feast for your senses with our Food & Drink Blog, a tantalizing part of STM Daily News. Get the latest articles, recipes, and foodie news delivered straight to your inbox. Satisfaction guaranteed!

SIGN UP TO RECEIVE THE LATEST RECIPES & FOODIE NEWS, PLUS SOME EXCLUSIVE GOODIES!

We don’t spam! Read our privacy policy for more info.


Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

Daily News

Is There an E. Coli Outbreak at McDonald’s? What You Need to Know

McDonald’s faces an E. coli outbreak linked to Quarter Pounders, with 75 cases reported. The company is investigating potential onion contamination and prioritizing customer safety.

Published

on

E. coli outbreak


In the fast-paced world of fast food, health and safety are paramount. Recently, McDonald’s has been at the center of an alarming E. coli outbreak linked to their popular Quarter Pounders. With at least 75 reported cases across 13 states, including serious hospitalization and even a death, many consumers are understandably concerned. Let’s break down the situation, what officials are saying, and how McDonald’s is responding to the crisis.

@stmblog

🚨 E. coli outbreak linked to McDonald’s Quarter Pounders! Stay safe & report any symptoms. Food safety is a top priority. 🍔 FoodSafety #ecolioutbreak2024 https://stmdailynews.com ♬ original sound – STMDailyNews – STMDailyNews

The Details of the Outbreak

Reports have confirmed that this E. coli outbreak is associated with Quarter Pounders sold across various McDonald’s locations. As of now, Colorado and Montana have recorded the highest number of illnesses, causing health officials to raise the alarm. The symptoms of E. coli infection can be severe and include stomach cramps, diarrhea, and vomiting, which can lead to life-threatening complications, especially in vulnerable populations.

Possible Cause: Onions?

Amidst this distressing news, McDonald’s has identified a potential link to onions used in their Quarter Pounder recipe. While investigations are ongoing, the company is taking proactive measures by gradually reintroducing the Quarter Pounder to their menu without the traditional onions. This decision reflects their commitment to ensuring customer safety while addressing supply issues that may have arisen from the outbreak.

McDonald’s Response

In light of the ongoing investigation, McDonald’s has expressed its dedication to maintaining high food safety standards. They have collaborated closely with health officials, including the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), to trace the source of the contamination and prevent further incidents.

As they navigate this situation, the fast-food giant is emphasizing transparency with their customers. They have urged people to stay informed through official communication channels and monitor updates about the progress of the outbreak and safety measures being undertaken.

Consumer Safety: What Can You Do?

As the situation unfolds, it is essential for consumers to remain vigilant about their food choices:

  1. Stay Updated: Follow news reports and health advisories to keep track of the latest developments regarding this outbreak and any additional safety alerts.
  2. Practice Good Hygiene: Always wash your hands before eating, and keep an eye on cleanliness when dining out.
  3. Consider Menu Options: If you’re concerned about the outbreak, consider ordering items that do not contain ingredients linked to health risks or opt for menu items that have been specifically noted as safe.
  4. Know the Symptoms: Familiarize yourself with the signs of E. coli infection, and if you or someone you know experiences severe symptoms following a visit to McDonald’s, seek medical attention immediately.

The recent E. coli outbreak tied to McDonald’s Quarter Pounders has undoubtedly raised concerns among consumers, but the company is actively working to address the situation and safeguard the health of its patrons. While it’s human nature to worry about food safety, especially with such a concerning issue at hand, it’s also important to empower ourselves with knowledge and the right precautions.

As McDonald’s rolls out their menu changes, we hope that they can swiftly resolve this situation, ensuring that everyone can enjoy their meals with renewed confidence. Let’s all take a moment to prioritize food safety in our daily dining habits, and keep the conversation going around this crucial topic. Always stay informed, stay safe, and enjoy your meals wisely!

Read the release from McDonald’s corporate news site https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html

Advertisement

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

https://stmdailynews.com/food-and-drink/

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

Lifestyle

Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers

Published

on

mac and cheese
Image: Adobe Stock

Mac and Cheese Recall

In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.

Scope of the Recall

The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:

  • Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
  • Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.

In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.

Cause of the Recall

According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.

“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.

Retailer Responses

Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.

Consumer Safety First

The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.

As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.

In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.

Advertisement

Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

https://stmdailynews.com/food-and-drink/

Author

  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts


Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

Trending