FDA CDC News

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

Published

9 months ago

November 12, 2023

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.

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

Source: FDA

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Lifestyle

Important Recall Alert: Expanded Produce Recall Due to Listeria Concerns

Published

3 days ago

July 23, 2024

Charles Elliot, Daily News Staff

In a significant public health alert, the Ohio Department of Agriculture (ODA) has announced an expanded recall of fresh produce supplied by Wiers Farm Inc., based in Huron County. This comes amidst growing concerns about potential listeria contamination, prompting vigilance among consumers shopping at select retailers, including Walmart, Aldi, and Kroger stores across Ohio and several other states.

people at supermarket. recall — Photo by Sebastián Mera Jaramillo on Pexels.com

What You Need to Know

On July 22, 2024, Wiers Farm Inc. expanded its voluntary recall to include additional produce items that were packed between July 5 and July 12. While there have been no reported illnesses or consumer complaints to date, the ODA is taking proactive measures to ensure public safety.

Affected Products

The recall includes a variety of retail packaged items and bulk produce sold at various grocery chains. Here’s a comprehensive list of the impacted products:

Retail Packaged Items

Sold at select Walmart stores in multiple states:

Wiers Farm Bagged Poblano – UPC 073064202581 – 16 oz bag
Wiers Farm Bagged Cubanelle – UPC 073064201836 – 16 oz bag
Wiers Farm Bagged Green Beans – UPC 073064200846 – variable weight bag
Wiers Farm Bagged Salad Cucumber – UPC 073064459619 – 2 lb. bag
Wiers Farm Bagged Serrano – UPC 073064201829 – 4 oz bag
Wiers Farm Organic Bell Pepper – UPC 073064201416 – 2 count tray
Wiers Farm Organic Cucumber – UPC 073064201423 – 2 count tray
Wiers Farm Organic Yellow Squash – UPC 073064201447 – 2 count tray
Wiers Farm Organic Zucchini Squash – UPC 073064201430 – 2 count tray

Sold at Aldi stores in Ohio and nearby states:

Freshire Farms Bagged Green Beans – 16 oz bag
Freshire Farms Bagged Jalapenos – 8 oz bag

Bulk Retail Items (sold individually or by the pound)

Anaheim peppers
Cilantro (sold in bunches)
Cubanelle peppers
Whole cucumbers
Green beans
Green Bell Pepper
Habanero peppers
Hungarian Wax peppers
Jalapeno peppers
Mustard Greens (sold in bunches)
Poblano peppers
Serrano peppers
Tomatillos

In Ohio, these bulk items were distributed to Walmart, Kroger, Save-a-Lot, and local food banks in Cleveland and Youngstown.

What Should Consumers Do?

The ODA is urging consumers who may have purchased any of the listed products to discard them immediately. It’s crucial to stay informed, as listeria monocytogenes can lead to serious health issues, particularly in vulnerable populations such as pregnant women, the elderly, and those with weakened immune systems. Symptoms of listeriosis can include fever, muscle aches, and gastrointestinal distress—anyone experiencing these symptoms after consuming the recalled products should seek medical attention promptly.

Commitment to Safety

Wiers Farm Inc. has expressed its dedication to resolving this situation and ensuring the safety of its products. The ODA is actively investigating the matter, a response initiated after potential contamination was flagged during routine testing by the Michigan Department of Agriculture and Rural Development.

Stay Informed

For further inquiries or concerns, consumers can reach out to Wiers Farm at 419-933-2161. It’s essential to stay updated on recalls and food safety alerts to protect your health and the health of your loved ones.

As we navigate through these recalls, let’s remain vigilant and prioritize food safety to ensure a healthy dining experience for everyone. Remember, when in doubt, it’s better to be safe than sorry—check your pantry and fridge today!

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Consumer Corner

Important Recall Notice: Wiers Farm, Inc. Announces Voluntary Recall of Cucumbers Due to Listeria Concerns

Wiers Farm recalls cucumbers due to Listeria risk. Discard affected products immediately.

Published

1 week ago

July 19, 2024

Hal Machina, Daily News Staff

In a decisive move to ensure consumer safety, Wiers Farm, Inc., a respected distributor based in Willard, OH, has announced a voluntary recall of select cucumber products over concerns of potential contamination with Listeria monocytogenes. This recall specifically targets a limited number of whole and bagged salad cucumbers, sourced from out of state and distributed under the Wiers Farm brand.

Recall Details

Date of Announcement: July 12, 2024
FDA Publish Date: July 16, 2024
Product Types: Whole cucumbers and 2 lb bagged salad cucumbers
Pack Dates: June 5, 2024 (whole cucumbers), June 5 and 6, 2024 (salad cucumbers)
Distribution: Select Walmart stores in Michigan, Indiana, and Ohio

Reason for Recall

The potential for contamination was identified through routine sampling by the Michigan Department of Agriculture and Rural Development (MDARD). While no illnesses or customer complaints have been reported to date, Wiers Farm is proceeding with the utmost caution to safeguard its customers.

About Listeria

Listeria monocytogenes is a bacteria capable of causing the serious infection known as listeriosis. It primarily affects pregnant women, newborns, the elderly, and adults with weakened immune systems. Symptoms include fever, muscle aches, nausea, and diarrhea. If you have consumed any of the recalled products and are experiencing these symptoms, it is advised to seek medical attention promptly. More information about Listeria can be found on the Centers for Disease Control and Prevention (CDC) website.

Product Identification

Whole Cucumbers: Approximately 1.5-2.5 inches in diameter and 6-9 inches in length
Bagged Salad Cucumers: Packaged in a clear bag with a blue base, marked with the specified pack dates

Consumer Action

Consumers in possession of the affected cucumbers are urged not to consume them. Even though the products are past their shelf life and likely out of distribution, if you still have them, please safely dispose of them immediately. Questions or concerns can be addressed by contacting Wiers Farm customer care at (419) 933-2161 or via email at customercare@wiersfarm.com.

Company Statement

Wiers Farm has expressed its commitment to the highest standards of food safety and health. “We have taken immediate steps to address this isolated incident and are collaborating closely with the Ohio Department other traceability data to ensure that the product in question is swiftly and effectively removed from all channels,” stated a company spokesperson.

Summary

This recall serves as a reminder of the importance of stringent safety measures in the food distribution process. Wiers Farm’s proactive steps in recalling potentially affected products underscore their dedication to consumer safety and health standards. Consumers are advised to follow recall instructions and dispose of any questionable products to ensure health and safety.

FDA notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria

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FDA CDC News

Immediate Recall Alert: Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad

Reser’s recalls Hill Country Fare Mustard Potato Salad due to potential plastic contamination. Return for a refund if purchased.

Published

1 week ago

July 18, 2024

Charles Elliot, Daily News Staff

In a decisive action prioritizing consumer safety, Reser’s Fine Foods has issued a voluntary recall for one of its popular products, the Hill Country Fare Mustard Potato Salad, available in 48 oz (3LB) containers. This recall specifically targets products with a Use By Date of JUL/26/24. The reason behind this precautionary step is the discovery of potential contamination from pieces of hard plastic, which could present a health risk to consumers.

Key Details of the Mustard Potato Salad Recall:

Company Announcement Date: July 02, 2024
FDA Publish Date: July 09, 2024
Product Type: Food & Beverages
Reason for Recall: Possibility of Hard Plastic Foreign Material
Company Name: Reser’s Fine Foods
Brand Name: Hill Country Fare
Product Description: Mustard Potato Salad

This product was exclusively distributed through H-E-B and Joe V’s Smart Shop stores located within Texas and was produced at a regional facility operated by Reser’s Fine Foods. It is important to note that, fortunately, no injuries or adverse effects have been reported as of now.

Consumer Safety Measures

To prevent any potential hazards, all affected product batches have been removed from retail shelves. Reser’s urges consumers who have purchased this specific product to avoid consuming it. Instead, they should return it to the store where it was purchased for a full refund or safely dispose of it.

Contact Information for Consumer Inquiries:

For those with further questions or in need of additional information regarding this recall, Reser’s Fine Foods has made provisions for customer communication. You can reach them at:

Phone: 888-223-2127
Operational Hours: Monday to Friday, from 8:00 AM to 5:00 PM Pacific Time.

Why This Recall Matters

Recalls are a vital part of ensuring safety in the food supply chain. Reser’s Fine Foods has taken this proactive step out of an abundance of caution to protect its consumers from any possible harm. Such actions reflect a commitment to high standards of food safety and consumer protection.

Taking Action

If you have purchased the recalled Hill Country Fare Mustard Potato Salad, check the packaging for the specified Use By Date, and follow the outlined safety guidelines. It’s also wise to keep abreast of updates from Reser’s Fine Foods and the FDA.

This voluntary recall showcases the importance of rigorous quality checks and responsiveness in addressing any potential risk swiftly. For continued safety, keep informed about the latest food recalls and guidelines issued by health and food safety organizations.

Closing Thoughts

Reser’s Fine Foods remains dedicated to upholding the highest levels of safety and quality and is actively working on measures to prevent future issues. Consumers can rest assured that swift actions like these reflect a commitment to their well-being.

For continuous updates, stay tuned to the FDA’s announcements or sign up for direct alerts from food safety authorities to ensure you and your lovedators are always protected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624

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