Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of HERCESSI™ (trastuzumab-strf)

HERCESSI™, a biosimilar to Herceptin®, is the first FDA-approved biosimilar from Accord BioPharma, with several more in development

DURHAM, N.C., April 29, 2024 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

“The approval of HERCESSI—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” said Chrys Kokino, U.S. president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”

HERCESSI is indicated for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 cancers in general are particularly aggressive cancer types that respond well to targeted treatment. HERCESSI works by binding to and inactivating the HER2 receptor, slowing down cell replication.

FDA approval was granted based on a comprehensive package of analytical, pre-clinical, and clinical data, which showed HERCESSI and its reference product, Herceptin (trastuzumab) are highly similar in terms of efficacy, safety, and quality. The clinical program for HERCESSI included three studies since 2015 to demonstrate pharmacokinetic (PK) comparability and clinical efficacy/safety similarity between HERCESSI and its reference product.

The studies include two Phase 1 comparative single-dose PK equivalence studies conducted in healthy volunteers (HLX02-HV01 and HLX02-HV02), and a supportive Phase 3, double-blind, randomized clinical efficacy and safety comparability study in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel (HLX02-BC01). The PK comparability and clinical efficacy/safety similarity exercised in HLX02-HV02 and HLX02-BC01 adheres to current biosimilar guidance from the FDA.

The safety profile of HERCESSI has been shown to be consistent with the safety profile for the reference product Herceptin. The data demonstrate that there are no clinically meaningful differences between HERCESSI and Herceptin in the populations studied and support biosimilarity between the two therapies.

“Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we’re just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings,” said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. “Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”

HERCESSI was approved by the FDA at a dosage of 150mg. A 420mg-strength version of HERCESSI is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024.

HERCESSI was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc. headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HERCESSI in the U.S. and Canada.

Mr. Jason Zhu, executive director, chief executive officer, and chief financial officer of Henlius remarked, “Henlius independently developed HLX02 (or HERCESSI in the U.S.) in accordance with the NMPA, the European Medicines Agency (EMA), the FDA, and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable, and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius’ response to patients’ concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics.”

HERCESSI is the first U.S.-FDA-approved biosimilar from Accord BioPharma, which has also submitted a Biologics License Application to the FDA for biosimilar versions of pegfilgrastim, filgrastim and ustekinumab. Accord BioPharma is planning on introducing several additional biosimilars to the U.S. market during the next five years.

Boxed Warning and Additional Important Safety Information

HERCESSI™ (trastuzumab-strf) for injection, for intravenous use.

HERCESSI (trastuzumab-strf) is biosimilar to HERCEPTIN (trastuzumab).

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
See full prescribing information for complete boxed warning.

Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greater risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCESSI for cardiomyopathy.

Infusion Reactions, Pulmonary Toxicity: Discontinue HERCESSI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.

Cardiomyopathy

• HERCESSI administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens.
• HERCESSI can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death.
• HERCESSI can also cause asymptomatic decline in LVEF by echocardiogram or MUGA scan.
• Evaluate left ventricular function in all patients prior to and during treatment with HERCESSI and every 6 months for at least 2 years following completion of HERCESSI as a component of adjuvant therapy.
• Discontinue HERCESSI treatment in patients receiving adjuvant therapy and withhold HERCESSI in patients with metastatic disease for clinically significant decrease in left ventricular function.
• The safety of continuation or resumption of HERCESSI in patients with trastuzumab product-induced left ventricular cardiac dysfunction has not been studied.

Infusion Reactions

• With trastuzumab products, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension were usually reported during or immediately following the initial infusion.
• Interrupt HERCESSI infusion for dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen).
• Monitor patients until symptoms completely resolve.
• Discontinue HERCESSI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions.
• Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.

Embryo-Fetal Toxicity

• Exposure to HERCESSI 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.
• Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCESSI.
• Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCESSI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERCESSI treatment and any potential adverse effects on the breastfed child from HERCESSI or from the underlying maternal condition. This consideration should also take into account the trastuzumab product wash out period of 7 months.

Pulmonary Toxicity

• HERCESSI administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions.
• Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
• Discontinue HERCESSI in patients experiencing pulmonary toxicity.

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 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 associated with trastuzumab products in the adjuvant and metastatic breast cancer (≥ 10%) are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
• The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Indications
Adjuvant Breast Cancer
HERCESSI (trastuzumab-strf) is indicated for adjuvant treatment of HER2-overexpressing nodepositive or nodenegative (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.

Metastatic Breast Cancer
HERCESSI 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.

Metastatic Gastric Cancer
HERCESSI 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.

Click here for full Prescribing Information, including Boxed Warnings.

About Accord BioPharma
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients’ perspective and develop high-quality therapies that impact patients’ lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.

References:
1. HERCESSI (trastuzumab-strf). Prescribing Information. Accord BioPharma; April 2024.
2. Accord BioPharma. Data on file.

Herceptin® is a registered trademark of Genentech, Inc.

Contact:
Nuvan Dassanaike
Senior Vice President Digital and Marketing Strategy & Operations
Nuvan_Dassanaike@Accord-Healthcare.com

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