KEYPOINTS:

• Biocon Biologics and Viatris Inc have launched Semglee (insulin glargine-yfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
• Biocon Biologics & Viatris’s interchangeable biosimilar Insulin Glargine injection will help increase access to this critical treatment for millions of Americans living with diabetes.
• In July 2021, the U.S. Food and Drug Administration (FDA) had approved our biosimilar Insulin Glargine-yfgn injection (Semglee®) as the first interchangeable biosimilar product under the 351(k) regulatory pathway, endorsing our scientific excellence and robust quality comparability data.

Biocon Biologics and its US-based partner Viatris Inc on Tuesday announced the introduction of two interchangeable biosimilar insulin injections in the American market.

Biocon Biologics and Viatris Inc have launched Semglee (insulin glargine-yfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.

Both biosimilar products are available in a vial and prefilled pen presentations and are interchangeable for the reference brand, Lantus (insulin glargine), allowing for substitution at the pharmacy counter.

“The launch of our interchangeable biosimilar insulin glargine in the US by our partner Viatris is in line with our aspiration to provide our biosimilar insulins to ’one in five’ insulin dependent people with diabetes, globally,” Biocon Biologics Deputy CEO Shreehas Tambe said in a statement.

Tambe added that this is a landmark event and along with the recent formulary listings, “we believe it will allow us to improve accessibility, availability and adoption of biosimilars in the US for the benefit of patients and the overall healthcare system”

Semglee and Insulin Glargine have been co-developed by Biocon Biologics and Viatris. The currently marketed non-interchangeable insulin glargine in the US market is anticipated to be phased out by the end of the calendar year 2021. “We are proud to stay true to that promise by bringing to millions of people with diabetes these interchangeable insulin biosimilar treatment options.”

“We are pleased to also offer a broad range of options to help patients, which are intended to maximise access to these important medicines, regardless of financial circumstances, insurance or channel,” Viatris Head of North America Jose Cotarelo said.

Viatris and Biocon Biologics, a subsidiary of Biocon, have an exclusive collaboration for the development, manufacturing and commercialisation of a broad portfolio of biosimilars and insulin analogs. Viatris has exclusive commercialisation rights in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries.

Biocon Biologics co-developed Semglee with Viatris and together they are committed to improving patients’ access to sustainable, high-quality and affordable biosimilars. As part of this commitment, Viatris will soon commercialize two versions of our landmark Insulin Glargine injection, the first-ever interchangeable biosimilar approved by the U.S. Food and Drug Administration (FDA): Semglee® (insulin glargine-yfgn) injection, a branded interchangeable product, and Insulin Glargine (insulin glargine-yfgn) injection, an authorized interchangeable biosimilar. Both products will be available in pen and vial presentations and are interchangeable for the reference brand, Lantus®. Semglee will also be included in Express Scripts’ Patient Assurance Program.

This dual product approach is intended to ensure that this historic interchangeable biosimilar insulin glargine can reach as many patients as possible regardless of financial circumstances, insurance or channel.

Dr Arun Chandavarkar, Managing Director, Biocon Biologics said :

“The inclusion of our interchangeable biosimilar insulin glargine in Express Scripts’ National Preferred Formulary® (NPF) in the U.S. is a major milestone for Biocon Biologics.  It furthers our mission of enabling affordable access to quality insulins to a large number of patients. We expect our partner to commercialize the product in the U.S. by end of the year and formulary coverage to begin in Jan 2022, making it an important growth driver for Biocon Biologics.”

“We believe adoption of biosimilars through PBMs like Express Scripts, will drive down the high cost of biologics therapy for chronic diseases like diabetes. Our biosimilar Insulin Glargine has the potential to bring significant cost savings for patients, employers and PBMs,” he added.

In July 2021, the U.S. Food and Drug Administration (FDA) had approved our biosimilar Insulin Glargine-yfgn injection (Semglee®) as the first interchangeable biosimilar product under the 351(k) regulatory pathway, endorsing our scientific excellence and robust quality comparability data.

Semglee^* (insulin glargine-yfgn) Injection and Insulin Glargine-yfgn Injection will be available in pharmacies before the end of the year, and further details related to our partner Viatris’ access programs, which aim to ensure that as many patients as possible will benefit from the product, will be available at that time.

The Express Scripts formulary change, including coverage of Semglee^* (insulin glargine-yfgn) on NPF, will occur effective January 1, 2022.

Express Scripts, Inc. is one of the largest PBMs in North America, providing services to thousands of client groups, including managed-care organizations, insurance carriers, employers, third-party administrators, public sector, workers compensation, and union-sponsored benefit plans.

Pharmacy benefit managers, or PBMs, are companies that manage prescription drug benefits on behalf of health insurers, Medicare Part D drug plans, large employers, and other payers.

Indications and Important Safety Information:

Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is not recommended for the treatment of diabetic ketoacidosis. Do not use during episodes of hypoglycemia or if hypersensitive to insulin glargine or its excipients. Patients should be instructed to never share the prefilled pen even if the needle is changed. Changes to a patient’s insulin regimen should be done under close medical supervision with increased frequency of blood glucose monitoring as hyper- or hypoglycemia may occur. Hypoglycemia is the most common adverse reaction with insulin, including Semglee and it may be life-threatening. Increase frequency of glucose monitoring when there are changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. Patients and caregivers must be educated to recognize and manage hypoglycemia. Medication errors can result from accidental mix-ups among insulin products. Instruct patients to always check the insulin label before injection. Severe, life-threatening generalized allergy, including anaphylaxis can occur with insulin products, including Semglee. If hypersensitivity reaction occurs, discontinue Semglee and treat per standard of care and monitor until symptoms and signs resolve.  Monitor potassium levels for hypokalemia and treat if indicated. Fluid retention and heart failure have been reported with concomitant use of thiazolidinediones (TZD). Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs.

What is interchangeable biosimilar insulin?

An interchangeable designation means that the product, marketed as Semglee, can be substituted for the reference product, Lantus, automatically by pharmacists without permission from a clinician, similar to generic drugs.

What type of insulin is glargine?

Insulin glargine is a long-acting, manmade version of human insulin. Insulin glargine products work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more suga

A drug used to control the amount of sugar in the blood of patients with diabetes. It is a form of the hormone insulin that is made in the laboratory. Insulin glargine controls blood sugar longer than insulin does. It is a type of therapeutic insulin.

Pharmacology:

Mechanism of action (MOA):

Insulin glargine differs from human insulin by replacing asparagine with glycine in position 21 of the A-chain and by carboxy-terminal extension of B-chain by 2 arginine residues. The arginine amino acids shift the isoelectric point from a pH of 5.4 to 6.7, making the molecule more soluble at an acidic pH and less soluble at physiological pH. The isoelectric shift also allows for the subcutaneous injection of a clear solution. The glycine substitution prevents deamination of the acid-sensitive asparagine at acidic pH. In the neutral subcutaneous space, higher-order aggregates form, resulting in a slow, peakless dissolution and absorption of insulin from the site of injection. It can achieve a peakless level for at least 24 hours.

Acceptance and repartition in the body:

Insulin glargine is formulated at an acidic pH 4, where it is completely water-soluble. After subcutaneous injection of the acidic solute (which can cause discomfort and a stinging sensation), when a physiologic pH (approximately 7.4) is achieved the increase in pH causes the insulin to come out of solution resulting in the formation of higher order aggregates of insulin hexamers. The higher order aggregation slows the dissociation of the hexamers into insulin monomers, the functional and physiologically active unit of insulin. This gradual process ensures that small amounts of insulin glargine are released into the body continuously, giving an almost peakless profile.

Why is this medication prescribed?

Insulin glargine products are used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Insulin glargine products are also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In people with type 1 diabetes, insulin glargine products must be used with another type of insulin (a short-acting insulin). In people with type 2 diabetes, insulin glargine products also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin glargine is a long-acting, manmade version of human insulin. Insulin glargine products work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Uses of Insuline Glargine:

Insulin glargine products come as a solution (liquid) to inject subcutaneously (under the skin). They are injected once a day. You should use insulin glargine products at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use insulin glargine products exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Never use insulin glargine products when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low.

Insulin glargine products control diabetes but do not cure it. Continue to use insulin glargine products even if you feel well. Do not stop using insulin glargine products without talking to your doctor. Do not switch to another brand or type of insulin or change the dose of any type of insulin you are using without talking to your doctor. Always check the insulin label to make sure you received the right type of insulin from the pharmacy.

Insulin glargine products come in vials and in dosing pens that contain cartridges of medication. Be sure you know what type of container your insulin glargine product comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.

If your insulin glargine product comes in vials, you will need to use syringes to inject your dose. Ask your doctor or pharmacist to show you how to inject insulin glargine using a syringe. Ask your doctor or pharmacist if you have questions about the type of syringe you should use.

If your insulin glargine product comes in pens, be sure to read and understand the manufacturer’s instructions. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully, and always perform the safety test before use.

Never reuse needles or syringes and never share needles, syringes, or pens. If you are using an insulin pen, always remove the needle right after you inject your dose. Discard needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Do not dilute insulin glargine products and do not mix insulin glargine products with any other type of insulin.

You can inject your insulin glargine in your upper arm, thigh, or stomach. Never inject insulin glargine into a vein or muscle. Change (rotate) the injection site within the chosen area with each dose; try to avoid injecting the same site more often than once every 1 to 2 weeks.

Always look at your insulin glargine product before you inject it. It should be clear and colorless. Do not use your insulin glargine product if it is colored, cloudy, or contains solid particles, or if the expiration date on the bottle has passed.

Do not use insulin glargine products in an external insulin pump.

Precautions:

Before using insulin glargine products,

• Tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), insulin glargine, insulin glargine-yfgn, any of the ingredients of insulin glargine or insulin glargine-yfgn, or any other medications. Ask your pharmacist or check the manufacturer’s patient information for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: albuterol (Accuneb, Proair, Proventil, others); prescription and nonprescription medications that contain alcohol; angiotensin-converting enzyme inhibitors (ACE inhibitors) such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), telmisartan (Micardis, in Micardis HCT, in Twynsta), valsartan (Diovan, in Diovan HCT, in Exforge); atypical antipsychotics such as clozapine (Clozaril, Fazaclo, Versacloz) and olanzapine (Zyprexa, in Symbyax); beta-blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol, nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal LA, Innopran XL); certain cholesterol-lowering medications such as fenofibrate (Antara, Lipofen, Triglide, others), gemfibrozil (Lopid), and niacin (Niacor, Niaspan); clonidine (Catapres, Catapres-TTS, Kapvay, in Clorpres, others); danazol; disopyramide (Norpace); diuretics (‘water pills’); estrogens; fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax); glucagon; guanethidine (not available in the U.S.); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), and saquinavir (Invirase); hormone replacement therapy and hormonal contraceptives (birth control pills, patches, rings, injections, or implants); isoniazid (in Rifamate, in Rifater); lithium (Lithobid); medications for asthma and colds; medications for mental illness and nausea; monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); octreotide (Mycapssa, Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met, in Oseni, others) and rosiglitazone (Avandia); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); pentamidine (NebuPent, Pentam); pentoxifylline (Pentoxil); pramlintide (Symlin); reserpine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate, diflunisal, magnesium salicylate (Doan’s, others), and salsalate; somatropin (Genotropin, Humatrope, Nutropin, Serostim, others); sulfa antibiotics; terbutaline; and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had nerve damage caused by your diabetes, heart failure, low blood levels of potassium; or any other medical conditions, including heart, liver or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using an insulin glargine product, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using an insulin glargine product.
• Alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using an insulin glargine product.
• Ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule. These changes can affect your blood sugar and the amount of insulin you will need.
• Ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.

Side effects this medication can cause:

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Insulin glargine products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, pain, or itching at the injection site
• changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)
• fever, cough, sore throat, or other signs of infection

Some side effects can be serious. If you experience these symptoms, call your doctor immediately or get emergency treatment:

• rash, hives, or itching all over the body
• wheezing
• difficulty breathing or swallowing
• fast pulse
• sweating
• swelling of the eyes, face, lips, tongue, or throat
• hoarseness
• weakness
• muscle cramps
• abnormal heartbeat
• sudden weight gain
• swelling of ankles or feet
• shortness of breath
• vision changes

Insulin glargine products may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

About Interchangeability:

An interchangeable biosimilar may be substituted for a reference product and may provide patients with greater access and drive conversion to biosimilars at the pharmacy counter.

About Biocon Biologics Limited:

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Five molecules from Biocon Biologics’ portfolio have been taken from lab to market, in developed markets like United States, EU, Australia, Canada, Japan and key emerging markets. It has many firsts to its credit including the most recent USFDA approval of world’s first interchangeable biosimilar, received for its Insulin Glargine. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.

About Biocon Limited:

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development.

About Viatris:

Viatris Inc. is an American global healthcare company headquartered in Canonsburg, Pennsylvania. The company was formed through the merger of Mylan and Upjohn, a division of Pfizer, on November 16, 2020.

The name of the company comes from the Latin words via, meaning path, and tris, which means three, referring to the path to three main objectives the company set. Viatris ranked 254th on the 2021 Fortune 500 rankings of the largest United States corporations by total revenue.

On November 16, 2020, Upjohn merged with Mylan in a Reverse Morris Trust transaction and changed its name to Viatris. At that time, Michael Goettler became chief executive officer. Following the combination, the company began trading on the NASDAQ using the ticker symbol VTRS.

In December 2020, the company announced a cost-reducing restructuring plan which would impact up to 20% of its global workforce, or 9,000 jobs at its facilities around the world. In 2021, Viatris was ranked 5th by Fortune on its annual “Change the World” list.

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