Semglee and Basaglar are brand-name drugs of long-acting insulin glargine products that are used for type 1 and type 2 diabetes treatment. They are both biologic drugs that are biosimilars to Lantus and have similar side effects. Semglee can now be substituted for Lantus without intervention of the prescriber, however, Basaglar cannot. Read on to find out about the similarities and differences between these drugs but let’s first look briefly at what biologic drugs are.
What is a biologic drug?
Biologics or biological medicines originate from living cells, such as humans, animals, or microorganisms using biotechnology, whereas chemically derived drugs are created in laboratories. Chemically derived or traditional drugs are described as small molecule drugs. Biologic drugs on the other hand are much larger in size, containing more complex molecules, making them challenging and costly to make. The growth of the cells in biologic medications can take several weeks and requires constant monitoring. The protein that makes up the drug is extracted and purified until the final biologic drug is obtained.
What is a biosimilar drug?
A biosimilar drug is a biological product that is very similar to another biological product known as the reference biologic (the original biologic). The reference biological medicine is the first brand to market. e.g. Lantus is the reference/original biologic and Semglee and Basaglar are the biosimilars. Much like how generic drugs are substituted for brand-name drugs.
A biosimilar has no clinically meaningful differences in safety, purity, and effectiveness from an existing FDA-approved reference product.
What is Semglee?
Semglee is an FDA (U.S. Food and Drug Administration) approved medication co-developed by Mylan Pharmaceuticals and Biocon Biologics. Semglee (insulin glargine-yfgn) is an interchangeable biosimilar insulin product with its reference product Lantus (insulin glargine) manufactured by Sanofi. A biosimilar needs to have special approval to be considered interchangeable with its brand name biologic drug. Semglee is in fact the first interchangeable biosimilar insulin product on the market given FDA approval. This now means a pharmacist can substitute Semglee for Lantus as a lower-cost alternative without permission from the prescriber.
It is important to understand that if Semglee is given to you instead of Lantus it is the same medication and is not a new insulin. Patient education is essential to avoid duplication of therapy.
Semglee is a long-acting human insulin analog indicated to:
- Improve glycemic control in adults and pediatric patients who have high blood sugar in type 1 diabetes mellitus and in adults with high blood sugar in type 2 diabetes mellitus
Semglee is not recommended for treating diabetic ketoacidosis.
What is Basaglar?
Basaglar is a long-acting form of insulin manufactured by Eli Lilly used to reduce high blood sugar levels. It’s prescribed to:
- Adults with type 1 or type 2 diabetes
- Children aged six or over with type 1 diabetes
How do Semglee and Basaglar work?
The active ingredient in Semglee and Basaglar is called insulin glargine. It’s a type of synthetic (man-made) insulin that’s similar to the insulin your body makes naturally. One of the main differences is that it has been designed to be longer acting.
When you inject Basaglar under your skin, insulin glargine is released into your bloodstream. Insulin glargine travels around your body and attaches itself to cells. As it does so, it causes your cells to release a substance that helps them absorb sugar from your blood. Insulin glargine can keep working for up to 24 hours, covering your insulin needs for up to a day.
Understanding insulin and long action insulin
Insulin is a natural hormone found in your body that helps you maintain a healthy blood glucose level. It is made by a small organ in your body called your pancreas. Your pancreas secretes insulin into your bloodstream where it helps to balance your blood glucose in two ways. Insulin accompanies the glucose in your blood and helps your cells absorb it. If you have more glucose in your blood than your cells need, insulin also signals to your liver to absorb and store the excess glucose so it can be used later when your blood glucose has fallen.
As well as the insulin produced in your body, synthetic (man-made) versions of insulin are also available. These work in the same way as the insulin made by your pancreas, but they have often been designed to be shorter or longer-acting versions.
Short-acting insulins are usually injected after a meal to help your body manage the glucose released as you digest it. Long-acting insulins are usually injected once per day to help your body maintain a healthy blood glucose level throughout the day and night. Long-acting and short-acting insulins are often used together. Semglee and Basaglar are both long-acting synthetic insulins. They can be active for up to 24 hours after injecting.
How do you inject Semglee and Basaglar?
Semglee and Basaglar are injected in the same way. You need to inject under your skin (subcutaneous injection) rather than into a vein or muscle. The fatty tissue just under your skin is the ideal place for the drug to be absorbed gradually. If you inject it deeper into your muscle your body will absorb it too quickly. The effects may not last long and will additionally be more painful. Judging the depth correctly can be quite difficult, particularly if you are slim but it is important to master the technique to stay safe.
Administer Semglee and Basaglar subcutaneously into the abdominal area, thigh, buttocks, or upper arms once daily at any time of day, but at the same time every day. These areas are likely to have enough body fat to allow you to easily inject. Rotate injection sites to reduce the risk of lipodystrophy. The importance of rotating injection sites should be noted to maintain effective drug absorption and prevent problems.
What doses of Semglee are available?
Semglee is available in injection form, in the following doses: 100 units/mL available as a 10 ml vial multiple-dose, or 3 ml single-patient-use prefilled pen. Injection prefilled pens can be a good option if you have difficulty drawing your insulin dose from a vial.
Always speak with a healthcare professional about any changes to your dose so they can monitor and evaluate your condition.
What doses of Basaglar are available?
Basaglar is available in injection form in the following doses: 100 units/mL available as 3ml drug solution in the Basaglar Kwik Pen or Basaglar Tempo as disposable prefilled pens. The Basaglar Tempo pen connects to a smartphone app to record insulin doses.
Semglee and Basaglar side effects
The most common side effects of Semglee and Basaglar include:
- Allergic reactions
- Injection site reactions like itching, rashes, skin thickening, or pits forming in your skin
- Edema and weight gain
These are the most common side effects associated with insulin glargine products.
Basaglar can also cause upper respiratory tract infection, runny or stuffy nose, back pain, cough, urinary tract infection (UTI), diarrhea, depression, and headache.
In rare instances, Semglee and Basaglar can cause more serious side effects. These can include:
- Hyperglycemia or hypoglycemia with changes in insulin regimen
- Hypoglycemia (low blood sugar) that may be life-threatening
- Medication errors due to accidental mix-ups between insulin products
- Hypersensitivity reactions – severe, life-threatening allergies, including anaphylaxis
- Hypokalemia – monitor potassium levels in patients at risk of hypokalemia and treat if indicated
- Fluid retention and heart failure with concomitant use of thiazolidinediones. Observe for signs and symptoms of heart failure
Get medical help right away if you have a rash over your whole body, difficulty breathing, a fast heartbeat, sweating, swelling of your face, lips, tongue, or throat, shortness of breath, extreme drowsiness, dizziness, or confusion.
Your doctor will assess the benefits of using Semglee and Basaglar against your risk of side effects. Patients are encouraged to report negative side effects or adverse reactions of Semglee to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Semglee and Basaglar drug interactions
Semglee and Basaglar can interact with other medications, including:
- Thiazolidinedione (TZD), taken to treat diabetes
- Any other diabetes medications
- Beta-blockers, taken to treat high blood pressure
- Angiotensin-converting enzyme (ACE) inhibitors, taken to treat high blood pressure and certain heart conditions
- Sulfonamide antibiotics
- Fibrates, taken to lower blood triglyceride levels
- Corticosteroids such as cortisone
- Protease inhibitors, taken for HIV/AIDS
- Diuretics, taken to make you urinate more
- Thyroid hormones, taken to treat thyroid gland disorders
- Pentamidine, an antimicrobial medication
This list is not exhaustive and other prescription drugs may interact with Semglee or Basaglar. If you’re unsure if you’re taking any of these, take the packaging of all your medications and supplements to your doctor or pharmacist.
Semglee and Basaglar warnings & precautions
Don’t take Semglee or Basaglar if you:
- Are allergic to the active ingredient insulin glargine
- Are allergic to any of the other ingredients in Semglee or Basaglar
- Are having a hypoglycemia episode
- Are under 18 years of age for type 2 diabetes
- Are under six years of age for type 1 diabetes
Talk to your doctor before taking Semglee or Basaglar if you:
- Are taking any of the medications that could interact with Semglee or Basaglar
- Have any heart problems
- Have any have liver or kidney problems
- Have low levels of potassium in your blood
- Are pregnant or are planning to become pregnant
- Are breastfeeding or are planning to breastfeed
- Are over 65 years of age
Discussing your medical history with your healthcare provider is important to help them understand how well Semglee or Basaglar will work for you. Give a complete list of all the prescription drugs, including over-the-counter meds, supplements, and medical conditions you may have. Talking with your doctor will allow them to pick up any drug interactions with Semglee and Basaglar and help manage any possible side effects.