New treatment approved buy FDA for HER2+

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https://www.drugs.com/history/herzuma.html?utm_sou...

Herzuma Approval History

Reviewed by J.Stewart BPharm. Last updated on Dec 19, 2018.

FDA Approved: Yes (First approved December 14, 2018)
Brand name: Herzuma
Generic name: trastuzumab-pkrb
Dosage form: Injection
Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer

Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer.

Indications and Usage

• Adjuvant Breast Cancer 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 consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • as part of a treatment regimen with docetaxel and carboplatin
• Metastatic Breast Cancer
  • in combination with paclitaxel for 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.
• In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
• Herzuma is administered as an intravenous (IV) infusion.

FDA approval of Herzuma was based on comprehensive data that demonstrated no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin for the treatment of HER2-overexpressing breast cancer.

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FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (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

Sassa

While I was once a strong proponent for generic drugs (thirty five plus years with the FDA in the areas of field inspections and product review of marketing applications, now retired), I now have serious concerns about the quality of the generic products being imported into the country because of the foreign inspection program, other concerns about the bioequivalence and bioavailability of the products, and the quality control at the manufacturing facility.

I would hate to be putting my life on the line with the new generic Herceptin products.