Press release

Novo Nordisk launches unbranded biologic of Tresiba^® analog insulin to expand affordability options for patients

PLAINSBORO, N.J., ( Sept 8 , 2022) – Novo Nordisk today announced the upcoming availability of an unbranded biologic of Tresiba^® (insulin degludec) injection, a once-daily long-acting basal insulin indicated to control high blood sugar in patients 1 year of age and older with diabetes. The unbranded biologic, insulin degludec, was approved by the US Food and Drug Administration (FDA) in July 2022 and will be available for prescription-holding patients to order from pharmacies nationwide later this Fall as part of an ongoing effort to expand affordability options for patients in need.

"Unbranded biologics are a part of our ongoing efforts to expand our options for patients who struggle to afford their prescribed insulin, support that is especially crucial for the uninsured and underinsured," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. "With the addition of this treatment to our portfolio, Novo Nordisk is now able to offer patients unbranded biologic options of both rapid- and long-acting insulins. We recognize that no single solution will work for everyone, and are committed to providing ongoing support to ensure that no patient has to go without insulin because they can’t afford it."

This unbranded biologic of Tresiba^® will launch at 65% off of the list price of Tresiba^® and will be distributed by Novo Nordisk Pharma, Inc. The list prices will be $118.63 for the U-100 10 ml vial, $177.95 for the U-100 FlexTouch^® 5x3 ml, and $213.54 for the U-200 FlexTouch^® 3x3 ml.

Affordability Options Available

In addition to the unbranded biologic insulins, Novo Nordisk has several important programs designed to address the accessibility and affordability of the therapies that patients rely on to manage their diabetes, including:

• My$99Insulin: 30-day supply of a combination of Novo Nordisk insulin products (up to three vials or two packs of pens) for $99 for eligible patients.   
• Immediate Supply: A free one-time immediate supply of Novo Nordisk insulin (up to three vials or two packs of pens) to eligible patients who may be at risk of rationing.   
• Patient Assistance Program (PAP): Provides free medicines, including all Novo Nordisk Inc. insulins and Novo Nordisk Pharma, Inc. unbranded biologics, to eligible patients. A family of four with an annual income up to $111,000 may receive free medications through our PAP. For individuals, the annual income limit for participation is $54,360.
• COVID-19 Patient Assistance Program: Created to reflect the growing economic toll caused by the pandemic crisis, we continue to offer 90 days of free insulin to eligible patients who lost health care coverage due to COVID-19 job loss, and will continue to evaluate program offerings to meet the needs of patients.
• Novo Nordisk human insulin: Available for about $25.00 per vial and slightly more when sold in a pen at national pharmacies like Walmart and CVS. About 500,000 Americans are using Novo Nordisk human insulin through these retailers.
• Copay Savings Cards: Coupons and copay card help defray high out-of-pocket costs for commercially insured patients. In 2021, Novo Nordisk provided approximately $100 million in copay assistance for insulin to patients.

Information about all of Novo Nordisk’s current affordability offerings can be found online at NovoCare.com. More information about insulin degludec and Tresiba^® are available by visiting Novo Nordisk Pharma, Inc. (NNPI) and Tresiba.com, respectively.

What is insulin degludec?

• Prescription insulin degludec is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes. This product is Tresiba (insulin degludec).
• Insulin degludec is not for people with diabetic ketoacidosis (increased ketones in the blood or urine)
• It is not known if insulin degludec is safe and effective in children under 1 year of age
• Insulin degludec is available in 2 concentrations: 200 units/mL and 100 units/mL

Important Safety Information

Do not share your insulin degludec FlexTouch^® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.

Who should not take insulin degludec?

Do not take insulin degludec if you:

• are having an episode of low blood sugar (hypoglycemia)
• have an allergy to insulin degludec or any of the ingredients in insulin degludec

Before taking insulin degludec, tell your health care provider about all your medical conditions, including if you are:

• pregnant, planning to become pregnant, or are breastfeeding
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

Talk to your health care provider about low blood sugar and how to manage it.

How should I take insulin degludec?

• Read the Instructions for Use and take insulin degludec exactly as your health care provider tells you to
• Do not do any conversion of your dose. The dose counter always shows the selected dose in units
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
• Adults - If you miss or are delayed in taking your dose of insulin degludec:
  • Take your dose as soon as you remember, then continue with your regular dosing schedule
  • Make sure there are at least 8 hours between doses
• If children miss a dose of insulin degludec:
  • Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of insulin degludec
• For children who need less than 5 units of insulin degludec each day, use an insulin degludec U-100 vial
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
• Do not reuse or share your needles or syringes with other people. You may give them a serious infection, or get a serious infection from them
• Never inject insulin degludec into a vein or muscle
• Never use a syringe to remove insulin degludec from the FlexTouch^® pen
• Insulin degludec can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking insulin degludec?

• Do not drive or operate heavy machinery, until you know how insulin degludec affects you
• Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol

What are the possible side effects of insulin degludec?

Insulin degludec may cause serious side effects that can be life-threatening, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heart beat, anxiety, irritability, mood changes, and hunger.
• Low potassium in your blood (hypokalemia)
• Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Insulin degludec. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.

• Common side effects may include serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.

Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please click here for insulin degludec Prescribing Information.

About Unbranded Biologics

The term “unbranded biologic” or “unbranded biological product” generally describes an approved brand name biological product that is marketed without its brand name (proprietary name) on its label. Unbranded biologics are not different in strength, dosage form, route of administration, or presentation compared to the brand name biological product. An unbranded biologic is considered by FDA to be equivalent to its brand name biological product because it is the same product as the brand name biological product.

About Novo Nordisk 
Novo Nordisk is a leading global health care company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 95 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long term and do business in a financially, socially, and environmentally responsible way. With US headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

About Novo Nordisk Pharma Inc. (NNPI):

Novo Nordisk Pharma, Inc. or NNPI is a Novo Nordisk A/S US company. It was formed to bring unbranded biologics of Novo Nordisk branded analog insulins at a reduced list price for people with diabetes who are facing affordability challenges in the US.

Further information

Media:
Allison Schneider (US)	+ 1 732-513-4875 (mobile)	aocd@novonordisk.com

 

Tresiba^® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

© 2022 Novo Nordisk All rights reserved. US22UMA00020 September 2022