Samsung Bioepis Announces US Launch of ONTRUZANT® (trastuzumab-dttb) for Early and Metastatic HER2-overexpressing Breast Cancer and Metastatic Gastric Cancer

Samsung Bioepis Co., Ltd. announced today that ONTRUZANT^® (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN^®1 (trastuzumab) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the United States. Patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ONTRUZANT^® is available in both 150 mg single-dose vials and 420 mg multi-dose vials. Please see Boxed Warnings and Important Safety Information for ONTRUZANT^® below.

The launch follows the approval from the US FDA in January 2019 for the 150 mg vial and in March 2020 for the 420 mg vial, based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical and clinical pharmacokinetic, safety and effectiveness data demonstrating that ONTRUZANT^® is highly similar to its reference product HERCEPTIN^®, and there are no clinically meaningful differences in terms of the safety, purity and potency of the product.^{i,ii,iii,iv,v,vi}

“The launch of ONTRUZANT^® to deliver our first oncology biosimilar in the US marks an important milestone for Samsung Bioepis, and more importantly, for the patients who are in need of this proven treatment,” said Christopher Ko, President and Chief Executive Officer, Samsung Bioepis. He continued, “While we understand that this is an unprecedented time for our hospitals and healthcare workers, we at Samsung Bioepis remain steadfastly committed to the patients we serve through our efforts to ensure the continued supply of our medicines through collaboration with our manufacturing and commercial partners.”

ONTRUZANT^® will be introduced in the US at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of HERCEPTIN^®. Wholesaler acquisition costs do not include discounts to payers, providers, distributors and other purchasing organizations.

ONTRUZANT^® will be marketed and distributed in the US by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off certain products, amongst them ONTRUZANT^® and its biosimilars businesses, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT^® until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT^® will become a product of the new company.

Under terms of agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration while Merck is responsible for commercialization activities for products approved in its partnered territories, including the US.

1 HERCEPTIN® is a registered trademark of Genentech Inc.

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
• As part of a treatment regimen 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

• Administration of ONTRUZANT ^® can result in sub-clinical and clinical cardiac failure
• Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT ^® . Discontinue ONTRUZANT ^® treatment in patients receiving adjuvant therapy and withhold ONTRUZANT ^® in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions; Pulmonary Toxicity

• Administration of ONTRUZANT ^® can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT ^® infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT ^® for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Embryo-Fetal Toxicity

• Exposure to ONTRUZANT ^® during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as 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. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

i Paek K, Kim GW, Ahn SY, Lim JH, Jung D, Kim S, Lee JH. (2019). Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar. BioDrugs 2019 Dec;33(6):661-671.

ii Lee JH, Paek K, Moon JH, Ham S, Song J, Kim S. Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment. BioDrugs (2019) 33:411-422.

iii Lee JH, Paek K, Kim E, Kim I, Jeong J, Kim S. Comparison of in vitro antitumor activity between SB3 (trastuzumab biosimilar, Ontruzant) and Herceptin combined with an antibody for subdomain II of HER2 in HER2-positive cancer cells. J Clin Oncol. 2019 37:15_suppl, e14001-e14001.

iv Pivot et al. A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects. Clin Ther. 2016 Jul;38(7):1665-1673.

v Pivot et al. Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer. J Clin Oncol. 2018 Apr 1;36(10):968-974.

vi Pivot et al. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results. Eur J Cancer. 2018 Apr;93:19-27.

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Contact information

MEDIA CONTACT:
Na Yun KIM
+82-31-8061-1604
nayun86.kim@samsung.com