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Now the pharmacy has 2 choices to dispense a less expensive biosimilar to Lantus® (insulin glargine) without needing to contact your office to make the change. Biological products are made from living sources (bacteria, yeast, animal cells), which can contain slight variations from batch to batch, making them more complicated to purify and process. Biological products such as insulin are classified as a “biosimilar” due to the rigorous approval standards required to prove safety and efficacy equivalent to the reference insulin.
This information is from the article written on Semglee in November 2021 for WAFP:
What is a “Biosimilar”? Per the FDA: “a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA”.
What is required for Interchangeability? The manufacturer needs to include data to show that the biosimilar can be expected to produce the same clinical result as the reference drug, without risks in terms of safety or diminished efficacy from switching back and forth. May be substituted without contacting the prescriber.
How is this different from Basaglar? Basaglar is also a biosimilar for Lantus®. However, it is not approved as an interchangeable biosimilar, so cannot be substituted for Lantus® to give the patient the cost savings at the point of care. It can only be dispensed after contacting your office to request the change, or if you write directly for it.
What is Rezvoglar? Insulin glargine-aglr is an injectable long-acting (basal) human insulin analog that is FDA approved to help control blood sugar in adults and children with Type 1 or Type 2 Diabetes Mellitus. It is available in 10ml vials and 3ml prefilled pens.
How much of a cost savings is it (really)?
|Basal Insulin Product||FDA Designation:||1 box of prefilled pens (~ 1500 units total)|
|Lantus U-100 Insulin glargine||Original Sanofi Branded Product||~ $400|
|Toujeo U – 300 insulin glargine||High Potency Branded Product||~ $350|
|Basaglar U-100 Insulin glargine biosimilar||Biosimilar, but not interchangeable||~ $350|
|Rezvoglar U -100 insulin glargine-aglr||Interchangeable biosimilar to Lantus||~ $90|
|Semglee U-100 insulin glargine-yfgn||Interchangeable biosimilar to Lantus||~ $280 - $400|
|Levemir Insulin||Novo Nordisk Branded Product||~$500|
|Tresiba U- 100 or U-200 Insulin degludec||Novo Nordisk Branded Product: Ultra Long Action Basal||~ $500|
What can I do to help my patients get this savings? If you are prescribing Lantus®, it will be automatically substituted at the pharmacy, so just know that your patients on Semglee® or Rezvoglar® are on an equivalent insulin to Lantus®.
In case you are curious about the 4 digit suffix attached to biosimilars, it was created to distinguish the biosimilar from the original product. The FDA guidance for this, from the AJMC Center for Biosimilars @ https://www.centerforbiosimilars.com/view/alphabet-soup-the-story-behind-biosimilar-nonproprietary-name-suffixes
The proposed suffix should:
The proposed suffix should not:
Reference: FDA’s Center for Drug Evaluation and Research. FDA approves second interchangeable insulin product, Rezvoglar (insulin glargine-aglr)
The Food and Drug Administration (FDA) recently released a press release announcing their intent to develop formal regulatory pathways for cannabidiol (CBD) containing products. Although such action will require working with Congress, they feel this action is necessary to balance the publics’ interest in using such products while at the same time mitigating risks that may exist with such use.
The FDA’s action came at the same time when they denied three citizen petitions asking for CBD products to be designated as dietary supplements. These requests were denied due to safety concerns the FDA cited, including:
If designated as a dietary supplement, the FDA would be limited in what tools and resources they would be able to use to ensure the safety of CBD’s use in the public.
If CBD containing products would be allowed to enter such regulatory pathways, specific tools and safeguards could be utilized to ensure a higher degree of safety for the general public who may use such products while at the same time minimizing risks. Examples of such tools and safeguards could include:
The FDA’s press release goes on emphasize that their desire to seek these regulatory actions with CBD-containing and cannabis-derived products centers around their mission to protect the public’s health and safety.
To read the press release in its entirety, click here: https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol
The Food and Drug Administration (FDA) approved a new, one-of-a-kind vibrating oral capsule for the management of chronic idiopathic constipation in August of 2022. The product, called Vibrant, is now available for providers to prescribe and patients to use, as of early February 2023.
The product does not contain any medication, and as such, the FDA has deemed it a Class 2 (intermediate risk) medical device, similar to contact lenses or syringes. It is indicated for the management of chronic idiopathic constipation not resulting in relief with laxatives at therapeutic doses for one month.
The pill is activated by inserting it into a pod. After activation, the patient swallows the pill at bedtime, and it traverses the gastrointestinal (GI) tract. It reaches the large intestine approximately 14 hours later, when it begins to work. The pill is designed to operate in a cycle of 2 hours on, 6 hours off, and another 2 hours on. While the device is in the active 2 hour phase, it vibrates for 3 seconds on and 3 seconds off. The vibrations, which are imperceptible to most patients, trigger peristalsis. In one clinical trial, Vibrant resulted in at least one additional bowel movement per week for 41% of participants vs. 23% of subjects assigned to placebo. The pills are subsequently excreted unchanged in the stool and flushed away. They are then filtered at water treatment facilities, separated as non-compostable waste, and sent to the landfill.
Many patients reported softer stools and less bloating with the vibrating pills vs. placebo. Vibrant is generally well-tolerated, but infrequently associated with various GI complaints ranging from abdominal pain, discomfort, and distention, to nausea, vomiting, and diarrhea.
The product should be avoided in patients with a history of gastroparesis, inflammatory bowel disease, gastrointestinal obstruction, diverticular disease, eosinophilic esophagitis, dysphagia, and other gastrointestinal comorbidities.
Currently, the device is only available from a single source (Carepoint specialty pharmacy - Schaumburg, Illinois) and is not covered by insurance. It retails for $89 month ($69 per month with prior authorization). Patients are allowed to use flexible spending accounts or health savings accounts to pay for Vibrant.
Clinical Pharmacy Practitioner in Primary Care
Mike Grunske, PharmD, BCPS
Mike Grunske is a Board-Certified Pharmacotherapy Specialist (BCPS). Mike transitioned his practice to the Clement Zablocki VA Medical Center where he has since practiced in the Primary Care Clinics as a Clinical Pharmacist Practioner. Within this role, his practice involves direct care and management of patients’ medication regimens. He has worked as an active preceptor for both pharmacy students and residents throughout his entire career. Mike is also Past-President and former Foundation Chair of the Pharmacy Society of Wisconsin (PSW).
Mike is married to a fellow PharmAid contributor (Vanessa Grunske). Together they have a teenage daughter and son. He enjoys traveling with his family, attending his kid’s cheer, baseball, and basketball events, and spending any available leftover time running and hunting.
Pharmacist at Advocate Aurora Health
Vanessa Grunske, PharmD, BCACP
Vanessa practices with Advocate Aurora Health in Milwaukee, where she sees patients at Aurora Sinai Medication Management Clinic and maintains a dispensing practice at St. Luke’s Medical Center. Board-certified in ambulatory care pharmacotherapy, her practice interests include diabetes, hypertension, smoking cessation, geriatrics, improving health literacy, and medication adherence. She particularly enjoys and spends a good share of her work hours teaching and mentoring pharmacy students, family medicine residents and pharmacy residents.
She and her husband, Mike, live in the Milwaukee area with their two teenage children. In her free time, she enjoys cooking, baking, visiting our national parks with her family or relaxing on a beautiful Caribbean beach.
Professor at Concordia University Wisconsin School of Pharmacy
Beth Buckley, PharmD, CDCES
Beth Buckley, PharmD, CDCES (Certified Diabetes Care and Education Specialist), is a Professor of Pharmacy Practice at the Concordia University Wisconsin School of Pharmacy, where she has a teaching role within all years of the curriculum with a focus on Applied Patient Care Skills Lab, Diabetes Pharmacotherapy, and electives in the areas of diabetes and wellness. Her current role is ambulatory care pharmacist where she works with a Collaborative Practice Agreement to provide chronic disease state management within a primary care clinic.
When not working, she enjoys reading, gardening, traveling with her husband, volunteering within the community, and active fun: hiking, biking, dog walking, practicing yoga, mindfulness, and living with intention and gratitude.
Disclaimer: The Wisconsin Academy of Family Physicians (WAFP) has entered into a business relationship with Pharm Aid to offer our members discounts and exclusive savings. This or other affinity program relationships presented by the WAFP in no way implies a WAFP endorsement of the program, supplier, or vendor.