SAMSUNG-BIOEPIS
21.1.2019 00:40:04 CET | Business Wire | Press release
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® 1 (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Please see Boxed Warnings and Important Safety Information for ONTRUZANT® below.
ONTRUZANT® is Samsung Bioepis’ first oncology biosimilar to receive FDA approval, and will be marketed and distributed in the United States (US) by Merck, which is known as MSD outside of the US and Canada.
“For many cancer patients in the US, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening the availability of approved treatments for cancer patients across the US.”
ONTRUZANT® was also approved by the European Commission (EC) in November 2017, and has since been launched in a growing number of European countries.
About ONTRUZANT (trastuzumab-dttb)
ONTRUZANT is indicated
for adjuvant treatment of HER2-overexpressing node-positive or
node-negative (ER/PR-negative or with one high-risk feature*) breast
cancer:
- As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
- With docetaxel and carboplatin
- As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
* High-risk is defined as
ER/PR positive with one of the following features: tumor size >2 cm, age
<35 years, or tumor grade 2 or 3.
ONTRUZANT is indicated:
- In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
ONTRUZANT is indicated, in
combination with cisplatin and capecitabine or 5-fluorouracil, for the
treatment of patients with HER2 overexpressing metastatic gastric or
gastroesophageal junction adenocarcinoma, who have not received prior
treatment for metastatic disease.
Select patients for therapy based
on an FDA-approved companion diagnostic for a trastuzumab product
Select Important Safety Information
Cardiomyopathy
- ONTRUZANT administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue ONTRUZANT for cardiomyopathy.
Infusion Reactions; Pulmonary Toxicity
- Administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
Embryo-Fetal Toxicity
- Exposure to ONTRUZANT during pregnancy can result in oligohydramnios in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Exacerbation of Chemotherapy-Induced Neutropenia
- In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions
- The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
- The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
These are not all of the risks associated with ONTRUZANT ® . For additional information on ONTRUZANT® indications, as well as Important Safety Information related to its use, including Boxed WARNINGS, please see the ONTRUZANT® Prescribing Information HERE
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung
Bioepis is a biopharmaceutical company committed to realizing healthcare
that is accessible to everyone. Through innovations in product
development and a firm commitment to quality, Samsung Bioepis aims to
become the world's leading biopharmaceutical company. Samsung Bioepis
continues to advance a broad pipeline of biosimilar candidates that
cover a spectrum of therapeutic areas, including immunology, oncology,
ophthalmology and hematology. Samsung Bioepis is a joint venture between
Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com
.
# # #
_____________________________
1 HERCEPTIN ® is a registered trademark of Genentech Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190120005023/en/
Contact:
Mingi Hyun +82-31-8061-1594 mingi.hyun@samsung.com
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Galderma Provides Progress Update Regarding RelabotulinumtoxinA Regulatory Submission in the United States1.7.2026 07:00:00 CEST | Press release
Galderma received a Complete Response Letter from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization Relfydess is approved in 33 markets and already launched in more than 20, including across Europe, the Middle East and Australia, with an encouraging early launch trajectory supported by positive healthcare professional feedback Regulatory filings in other territories are ongoing and remain on track Ad hoc announcement pursuant to Art. 53 LR Galderma (SIX: GALD) today provided progress updates regarding the regulatory review of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA with the U.S. Food and Drug Administration (“FDA”). The Company has received a Complete Response Letter (CRL) from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization. As part of its review, the FDA conducted a Pre-License Inspection (PLI) of Galderma’s manufa
EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 03:45:00 CEST | Press release
EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 01:56:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release
FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
