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First Biosimilar Avastin® and Herceptin® Articles to Barrage in the United States



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THOUSAND OAKS, Calif., July 18, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today appear that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now accessible in the United States (U.S.).

MVASI, the aboriginal oncology ameliorative biosimilar accustomed by the U.S. Food and Drug Administration (FDA), is accustomed for the analysis of bristles types of cancer: in aggregate with chemotherapy for metastatic colorectal blight (mCRC); in aggregate with chemotherapy for non-squamous non-small corpuscle lung blight (NSCLC); alternate glioblastoma; in aggregate with interferon-alfa for metastatic renal corpuscle carcinoma; and in aggregate with chemotherapy for persistent, recurrent, or metastatic cervical cancer.



KANJINTI is FDA accustomed for all accustomed break of Herceptin: for the analysis of HER2-overexpressing accessory and metastatic breast blight and HER2-overexpressing metastatic belly or gastroesophageal alliance adenocarcinoma.

“The addition of biosimilars is an important footfall in accretion options for alleviative HER2-positive breast cancers, which annual for about 25% of all breast cancers,” said Paula Schneider, arch controlling officer, Susan G. Komen Breast Blight Foundation. “As accommodating advocates, we are alive to ensure that patients are accomplished about biosimilars and accept that these FDA-approved treatments are aloof as able as the aboriginal biologic drugs.”



The Wholesale Acquisition Amount (WAC or “list price”) of both MVASI and KANJINTI will be 15% lower than their advertence products. MVASI is actuality fabricated accessible at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% beneath than the WAC for Avastin. KANJINTI is actuality fabricated accessible at a WAC of $3,697.26 per 420 mg multi-dose vial, 15% beneath the WAC of Herceptin. At launch, MVASI is priced 12% beneath the accepted Avastin Average Selling Amount (ASP) and KANJINTI is priced 13% beneath the accepted Herceptin ASP. Both articles will be accessible from both wholesalers and specialty distributors.

“Several years ago, Amgen fabricated the cardinal accommodation to advance in architecture a all-around biosimilars business, leveraging our about four decades of acquaintance in developing and accomplishment best-in-class biologics,” said Murdo Gordon, controlling carnality admiral of All-around Bartering Operations at Amgen. “Following several contempo launches in Europe, we are aflame to be ablution our aboriginal two biosimilars in the U.S., which will accommodate for actual accumulation for Medicare patients and bartering payers. We accept several added biosimilars advancing through our pipeline, alike as we abide to drive addition through atypical therapies for blight and added austere diseases.”

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The WAC amount admeasurement does not annual for discounts and rebates and may be decidedly college than abroad amount for patients, which can alter depending on several factors. Medicare and bartering insurance, for example, will about pay for MVASI and KANJINTI based on ASP rather than WAC. Abroad amount may additionally depend on and be bargain by added factors, including accommodation for accommodating assistance.

Actual costs to patients and providers for MVASI and KANJINTI are advancing to be lower than WAC as WAC does not reflect discounts or rebates. Abroad costs to patients will alter depending on allowance cachet and accommodation for accommodating assistance. MVASI and KANJINTI will be accessible from both wholesalers and specialty distributors.

“As the aboriginal articles from our accord with Amgen to be launched in the U.S., MVASI and KANJINTI reinforce our advancing adherence to accouterment patients with added analysis options,” said David Nicholson, arch analysis and development administrator at Allergan. “We are aflame about the advance we’ve fabricated through this affiliation and attending avant-garde to connected milestones calm with our actual biosimilar products.”

Amgen and Allergan are committed to developing high-quality biosimilars accurate by able-bodied analytic and analytic packages. MVASI and KANJINTI were accurate to be awful agnate to, and to accept no clinically allusive differences in agreement of assurance and capability from Avastin and Herceptin, respectively, based on a accumulation of evidence, which included allusive analytical, analytic assurance and ability data. At the time of FDA approval, KANJINTI was the alone trastuzumab biosimilar to absorb the appraisal of a distinct alteration in the analytic study, in which a allocation of patients who began the abstraction on Herceptin fabricated a distinct alteration to KANJINTI. This allocation of the abstraction accustomed agnate assurance and immunogenicity in patients on KANJINTI who were ahead on Herceptin.

Amgen has a absolute of 10 biosimilars in its portfolio, three of which accept been accustomed in the U.S.

About MVASI™ (bevacizumab-awwb) in the U.S.
MVASI is a recombinant humanized monoclonal IgG1 antibiotic that binds VEGF and prevents the alternation of VEGF to its receptors (Flt-1 and KDR) on the apparent of endothelial cells. The alternation of VEGF with its receptors leads to endothelial corpuscle admeasurement and new claret barge accumulation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon blight in nude (athymic) mice acquired abridgement of microvascular advance and inhibition of metastatic ache progression.

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MVASI, in aggregate with intravenous fluorouracil-based chemotherapy, is adumbrated for the first- or second-line analysis of patients with metastatic colorectal blight (mCRC).

MVASI, in aggregate with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is adumbrated for the second-line analysis of patients with mCRC who accept progressed on a first-line bevacizumab-containing regimen.

Limitations of Use: MVASI is not adumbrated for accessory analysis of colon cancer.

MVASI, in aggregate with carboplatin and paclitaxel, is adumbrated for the aboriginal band analysis of patients with unresectable, locally advanced, alternate or metastatic non-squamous non-small corpuscle lung blight (NSCLC).

MVASI is adumbrated for the analysis of alternate glioblastoma (GBM) in adults.

MVAS, in aggregate with interferon-alfa, is adumbrated for the analysis of metastatic renal corpuscle blight (mRCC).

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MVASI, in aggregate with paclitaxel and cisplatin or paclitaxel and topotecan, is adumbrated for the analysis of patients with persistent, recurrent, or metastatic cervical cancer.

MVASI (bevacizumab-awwb) Professional Important Assurance Information
Gastrointestinal (GI) perforation

Surgery and anguish healing complications

Hemorrhage

Additional austere and sometimes baleful adverse contest with added accident in the bevacizumab-treated arm vs chemotherapy arm included:

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