FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Health, Medicine

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers

PR Newswire

SILVER SPRING, Md.Dec. 1, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

As with any treatment, health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping (insomnia), cough and rash. Common expected side effects of Ogivri for the treatment of HER2+ metastatic stomach cancer include low levels of certain white blood cells (neutropenia), diarrhea, fatigue, low levels of red blood cells (anemia), inflammation of the mouth (stomatitis), weight loss, upper respiratory tract infections, fever, low levels of blood platelets (thrombocytopenia), swelling of the mucous membranes (mucosal inflammation), common cold (nasopharyngitis) and unusual taste sensation (dysgeusia). Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for Ogivri contains a Boxed Warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity) and harm to a developing fetus (embryo-fetal toxicity). Patients should stop taking Ogivri if cardiomyopathy, life-threatening allergic reactions (anaphylaxis), swelling below the skin (angioedema), inflammation of the lungs (interstitial pneumonitis) or fluid in the lungs (acute respiratory distress syndrome) occur. Patients should be advised of the potential risk to a developing fetus and to use effective contraception.

The FDA granted approval of Ogivri to Mylan GmbH. Herceptin was approved in September 1998 and is manufactured by Genentech, Inc.

For more information:
FDA: Information on Biosimilars
FDA: Biologics Price Competition and Innovation Act of 2009
FDA: Office of Hematology and Oncology Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approves SUBLOCADE™ (Buprenorphine Extended-Release), the First and Only Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder


SUBLOCADE Expected to be Available to U.S. Patients in Q1 2018

This announcement contains inside information.

Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved SUBLOCADETM(buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days. SUBLOCADE is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support1. SUBLOCADE is expected to be available to patients in the U.S. in Q1 2018.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8221151-indivior-sublocade-buprenorphine-fda-approval/

“SUBLOCADE is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program,” said Shaun Thaxter, Chief Executive Officer of Indivior. “In the Opioid Blockade Study, SUBLOCADE achieved complete blockade of drug-liking effects for a full month in most patients. SUBLOCADE is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a one month period. The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency. SUBLOCADE’s approval is an important step forward for patients, families and communities battling the opioid epidemic.”

SUBLOCADE contains buprenorphine, a partial agonist at the mu-opioid receptor1. Mu-opioid receptors in the brain are known to mediate the subjective effects of opioids, including drug-liking, which is the pleasure associated with opioid use2. SUBLOCADE delivers sustained plasma levels of buprenorphine that translate into high mu-opioid receptor occupancy in the brain, which blocks the drug-liking effects of opioids1.

In the SUBLOCADE clinical trial program, average buprenorphine plasma concentrations of 2-3 ng/mL were associated with mu-opioid receptor occupancy ≥70% and the reduction of illicit opioid use.  SUBLOCADE 300 mg delivers average buprenorphine plasma levels of approximately 2 ng/mL after the first injection. The average concentration of SUBLOCADE at steady-state was 3.21 ng/mL and 6.54 ng/mL for the 100 mg and 300 mg doses, respectively1.

Indivior conducted an Opioid Blockade Study (RB-US-13-0002) which investigated the ability of SUBLOCADE 300 mg to block the subjective effects of illicit opioids, including drug-liking. In the 12-week trial evaluating the blocking effect, SUBLOCADE 300 mg fully blocked the drug-liking effects of hydromorphone1.  Hydromorphone is a potent opioid pain medication3 that is commonly used in human studies to evaluate opioid drug-liking2.

SUBLOCADE was evaluated in a 24-week, Phase 3 pivotal study (RB-US-13-0001) in which patients were randomized to one of the following three regimens: six once-monthly SUBLOCADE 300 mg doses; two once-monthly SUBLOCADE 300 mg doses followed by four once-monthly 100 mg doses; or six once-monthly injections of placebo. Both dosage regimens of SUBLOCADE were shown to be superior to placebo in achieving more illicit opioid-free weeks (p<0.0001)1,4. In the clinical trials, the overall safety profile for SUBLOCADE, given by a healthcare provider, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions. The most common adverse reactions (≥5% patients), included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Injection site reactions were reported in 16.5% of the patients.  None of the injection site reactions were serious, and only one led to study treatment discontinuation1.

“Every patient’s journey to recovery is different and they face many challenges. To help support these differences, doctors and patients need options for medication-assisted treatment,” said Dr. Brent Boyett, SUBLOCADE clinical investigator and director at Boyett Health Services, Inc. “In a Phase 3 clinical study, SUBLOCADE helped patients refrain from illicit opioids for more weeks compared to placebo. Used in combination with counseling and psychosocial support, SUBLOCADE is a transformational new drug that offers a treatment option for people with moderate to severe opioid use disorder.”

The opioid addiction epidemic in the U.S. is a national public health emergency, with nearly 12 million people impacted nationwide and an average of four people dying from opioid overdose every hour of every day5,6,7. OUD, commonly referred to as opioid addiction8, is a chronic disease that changes the brain9. The patient journey to treatment and recovery is complex, with many barriers such as social stigma, access to treatment and prescribers, and difficulty adhering to treatment plans. Out of the more than 2.5 million patients diagnosed with OUD in the U.S., less than half are treated with medication-assisted treatment (MAT)10.

The economic impact of the opioid epidemic to the healthcare system is significant. The amount paid for treatment of substance use disorders is only a small portion of the costs these disorders impose on society. Data published in 2016 presented the total costs of prescription opioid use disorder and overdose in the U.S. at $78 billion in 2013. Of that, only 3.6 percent, or about $2.8 billion, was for treatment11.  A separate, recent analysis by the White House Council of Economic Advisers estimated the total annual cost of prescription opioid overdose, abuse and dependence in the U.S. at $504 billion in the year 201512. Patients, physicians, policymakers and other stakeholders have expressed the need for additional treatment options in the fight against the chronic relapsing disease of opioid addiction. Indivior has an ongoing, prospective, observational study (RECOVERTM) to understand the clinical, environmental and socioeconomic characteristics of OUD patients13.

“The American Society of Addiction Medicine supports the development and manufacturing of medications that aid in the treatment of addiction,” said Dr. Kelly Clark, President, American Society of Addiction Medicine. “The introduction of novel pharmacotherapies supports this goal. Addiction patients, like all patients, should have available to them a robust and varied array of treatment options, as no one treatment modality is appropriate or therapeutic for everyone.”

“We applaud the scientists and leaders who have been working tirelessly on the development of new, longer-acting medicines for the treatment of opioid use disorder. These exciting new developments will help our patients and families live healthy lives and accelerate the progress in the treatment of addiction,” commented Jessica Hulsey Nickel, President and CEO of the Addiction Policy Forum.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of SUBLOCADE in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription1.

SUBLOCADE will be distributed through a restricted distribution system, which is intended to prevent the direct distribution to a patient. This is because of risk of serious harm or death that could result from intravenous self-administration.

Indivior worked closely with the FDA to include appropriate warnings and precautions, including a BOXED WARNING in the label and implementation of a Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in the SUBLOCADE REMS Program. In addition, Indivior continues to enhance its compliance program to keep pace with the anticipated increase in the number of patients in treatment.

Switching to Toujeo® in a real-world setting produced a similar number of severe low blood sugar events as insulin degludec

Health, Medicine

Two large real-world analyses compared adults with type 2 diabetes who were switched to Toujeo (insulin glargine injection 300 Units/mL) to those switched to insulin degludec

PR Newswire

LOS ANGELESNov. 30, 2017 /PRNewswire/ — Adults with type 2 diabetes who switched their basal insulin therapy to Toujeo® or insulin degludec, experienced similar numbers of low blood sugar (hypoglycemia) events, according to the findings of two comparative real-world studies. Patients also experienced similar reduction of average blood sugar (HbA1c) with the different insulin treatments.

The results were presented today at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S.1,2

The two studies, known as LIGHTNING and DELIVER D, are part of the comparative study program for Toujeo versus insulin degludec. Both studies were retrospective observational analyses based on two different large U.S. databases of electronic medical records and claims using a statistical technique (propensity score matching) for making the treatment groups comparable. This minimizes observed sources of bias typically found in simple observational studies.

“With the patient matching approach used in the two studies, physicians and payers will have access to additional findings to evaluate Toujeo in a real-life setting,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi. “Data evaluating the risk of severe low blood sugar (hypoglycemia) can also help educate providers on treatment options.”

LIGHTNING: The largest real-world comparative study in diabetes

The LIGHTNING retrospective observational study1 is the largest real-world comparative study in diabetes. It used statistical techniques, such as propensity score matching and predictive modeling, to evaluate electronic medical records for 130,155 adult patients who were treated with long-acting insulin treatment in the U.S. Optum-Humedica database.

After Propensity Score Matching (PSM), 8,456 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups. Analysis showed that the risk of severe hypoglycemia related to an inpatient or emergency department visit was comparable in both groups of patients (p=0.37) with no differences in HbA1c.

DELIVER D: Further results from the DELIVER comparative program

In the DELIVER D retrospective observational study2, it used electronic medical records (EMR) for 22,492 adult patients who were treated with long-acting insulin treatment in the U.S. Predictive Health Intelligence Environment (PHIE) database. After PSM, 1,620 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups.

During the 6-month follow-up period, patients in both groups showed comparable numbers of patients experiencing any low blood sugar (hypoglycemia) events (p=0.45). The number of patients experiencing low blood sugar events associated with hospital or emergency department visit was also similar in both groups (p=0.80). Reduction in average blood sugar levels (HbA1c) were comparable between the two groups (p=0.97). Patients on Toujeo and those on insulin degludec were equally likely to attain HbA1c < 7.0% (12.9% vs 15.9%, respectively; P = 0.24) and HbA1c < 8.0% (44.2% vs 44.6%, respectively; P = 0.92) during 3-6 months’ follow-up.

While the findings from both studies represent actual patterns of treatment and outcomes outside the confines of clinical trials, electronic medical records are not completed for research purposes and vary in completeness. As a result limitations of these analyses include potential incomplete dosage information, under-reporting of hypoglycemia, and lack of information about reasons for switching treatment. In addition, the PSM process results in a smaller overall dataset compared with the available patient data pool.

What is Toujeo® (insulin glargine injection) 300 Units/mL?

Prescription Toujeo® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.

  • Toujeo® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)
  • Toujeo® is not for use to treat diabetic ketoacidosis
  • Toujeo® should not be used in children

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.

Do NOT reuse needles or share insulin pens even if the needle has been changed.

Before starting Toujeo®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breastfeeding or planning to breastfeed.

Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo®. Your treatment with TZDs and Toujeo® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms including:

  • Shortness of breath
  • Sudden weight gain
  • Swelling of your ankles or feet

Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, and herbal supplements.

Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including Toujeo®. Do not change your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Do NOT use a syringe to remove Toujeo® from your SoloStar® pen. Your dose for Toujeo® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.

While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect of any insulin, including Toujeo®, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Toujeo® may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

  • A rash over your whole body
  • Shortness of breath
  • Swelling of your face, tongue, or throat
  • Extreme drowsiness, dizziness, or confusion
  • Trouble breathing
  • Fast heartbeat
  • Sweating

Toujeo® may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

Toujeo® SoloStar® is a disposable prefilled insulin pen. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.

Please see full Prescribing Information for Toujeo® on Toujeo.com or click here: http://products.sanofi.us/Toujeo/Toujeo.pdf.


  1. Zhou LF et al, “Hypoglycemia risk associated with basal insulin use in type 2 diabetes (T2DM): The Lightning study”, World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2.
  2. Blonde L et al, “Real-world evidence demonstrates comparable clinical outcomes of switching from insulin glargine 100 U/mL (Gla-100) to insulin glargine 300 U/mL (Gla-300) vs insulin degludec (IDeg) in patients with type 2 diabetes (T2D)”, World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2.

About Sanofi

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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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