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This application was conceptualized but not approved by the EMA [22], and it involves any biological manufacturing request that depends on its own manufacturer In response, the FDA has probed pharmaceutical manufacturers to closely monitor March 2019 – Pfizer received FDA approval for TRAZIMERA, a biosimilar of SSM Health Insurance Company and SSM Health Plan. TRAZIMERA ( trastuzumab-qyyp) EFFECTIVE 02/01/2020, HERZUMA, TRAZIMERA, OGIVRI,. The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab. Name and address of the manufacturer(s) of the biological active substance(s).

About TRAZIMERA (trastuzumab-qyyp) TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some Biosimilars create a more competitive pricing environment among drug manufacturers that can help drive down drug costs. UnitedHealthcare evaluates each brand name biologic and its biosimilar, one by one, and makes a strategic management decision based on the lowest-cost product in order to deliver lower costs to our members, clients and consumers. Brand Name: Trazimera . Strength: 440 mg lyophilized powder per vial and 150 mg lyophilized powder per vial .

Trazimera contains the active substance trastuzumab. TRAZIMERA for Injection (trastuzumab-qyyp) This product information is intended only for residents of the United States. for Consumers: Pfizer Oncology Together Trazimera’s data package that led to approval included findings from the comparative clinical trial for the biosimilar, REFLECTIONS B327-02.

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• This program is not valid where prohibited by law. Is your Trazimera Qyyp medication too expensive? Through NiceRx, you may be able to get Trazimera Qyyp for only $49 per month.* NiceRx works with your healthcare provider to help you access affordable medications directly from U.S. pharmaceutical companies.

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Name of the manufacturer : Pfizer Form : Pd. Perf.

Trazimera, PULVER TIL KONSENTRAT TIL INFUSJONSVÆSKE, oppløsning: Styrke Pakning Varenr. SPC 1 Refusjon 2 Byttegruppe Pris (kr) 3 R.gr. 4; 150 mg: 1 stk. (hettegl En injektionsflaska med Trazimera som är aseptiskt spädd med sterilt vatten för injektionsvätskor (ej bipackat) är kemiskt och fysikaliskt stabilt i 48 timmar vid 2 °C–8 °C efter utspädning och får ej frysas. Trazimera 150 mg pulver till koncentrat till infusionsvätska, lösning.
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Because when it comes to support, we're in this together. For live, personalized support, call 1-877-744-5675 . Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Trazimera 150 mg powder for concentrate for solution for infusion. One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by chromatography including specific viral inactivation and removal procedures. Ogivri (Mylan/Biocon), Herzuma (Celltrion/Teva), Ontruzant (Samsung Bioepis/Merck), Kanjinti (Amben), and Trazimera (Pfizer) are the only approved trastuzumab biosimilars to date. Kanjinti and Ogivri launched in the summer of 2019, Pfizer launched Trazimera in February 2020, and Teva launched Herzuma one month later.

It is highly similar to the reference product Herceptin (trastuzumab), which was authorised in the EU on 28 August 2000. Data show that Trazimera has comparable quality, safety and efficacy to Herceptin (trastuzumab). More information on biosimilar medicines can be found here. The full indication is: Trazimera (trastuzumab) is a member of the HER2 inhibitors drug class and is commonly used for Breast Cancer, Breast Cancer - Adjuvant, Breast Cancer - Metastatic, and others. Trazimera Prices The cost for Trazimera intravenous powder for injection qyyp 420 mg is around $3,550 for a supply of 1 powder for injection, depending on the pharmacy you visit. Biosimilars create a more competitive pricing environment among drug manufacturers that can help drive down drug costs.
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Consumer Medicine Information (CMI) about Trazimera (Trastuzumab) intended for persons living in Australia. Injectables for TRAZIMERA provides eligible commercially insured patients with assistance of up to $25,000 per calendar year. Eligible enrolled patients may pay as little as $0 for each TRAZIMERA treatment. Federal and state health care beneficiaries not eligible.

It does not cover or provide support for supplies, services, procedures, or any other physician-related services associated with TRAZIMERA (trastuzumab-qyyp) is an FDA-approved biosimilar* • You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars (October 30, 2019) The New York–based pharmaceutical manufacturer plans to begin marketing Ruxience in January 2020, and Trazimera February 15, 2020. Find information about TRAZIMERA™ (trastuzumab-qyyp), an FDA-approved biosimilar of HERCEPTIN® (trastuzumab), on the HCP site.
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Erik Isakson / Getty Images Contract manufacturing occurs when a small business hires another Apr 30, 2021 Manufacturer / PAP Name. Support Offered Manufacturer Patient Assistance Programs.