Biosimilar Drug Profile: Mvasi is a biosimilar version of bevacizumab (reference product, Avastin) manufactured by Genentech (a subsidiary of Roche). It was the first anti-cancer biosimilar to be approved by the FDA.
The biosimilar was originally designated ABP-215. A biologic license application for its approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in November 2016. The FDA’s Oncology Drug Advisory Committee unanimously recommended the approval in July 2017. The FDA approved Mvasi for use in September 2017, with extrapolation to all of Avastin’s indications. Mvasi was also approved for use in the EU in January 2018.
Amgen began marketing Mvasi in July 2019.
About the Manufacturer
Amgen, based in Thousand Oaks, California is a leading biotechnology company. Allergan based in Dublin, Ireland is a global pharmaceutical company.
The two companies formed a collaboration in December 2011 to develop and commercialize four oncology biosimilar products. In this partnership, Amgen takes the lead for developing and manufacturing the products as well as directing the marketing efforts. Mvasi was the first approved biosimilar for the two partners.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Mvasi is the first bevacizumab biosimilar to be approved by the FDA. The product has not yet entered the marketplace. Pfizer’s Zirabev was approved by the FDA on June 27, 2019, and is also now available for use. Samsung Bioepis and its partner Merck submitted an application in November 2019 for SB 8, and a decision is expected in the fourth quarter of 2020. Likewise, partners Mylan and Biocon submitted their agent MYL-1402O for FDA approval; its application was accepted in December 2019, with a decision date of December 20, 2020.
Company name |
Product Name |
Stage of Development |
Bio-Thera Solutions |
BAT-1706 |
Phase III trial for lung cancer underway, company anticipates FDA filing in 2020 |
Boehringer Ingelheim |
BI 695502 |
Phase III trial for lung cancer completed in November 2018, no extended plans to develop further in US |
Celltrion |
CT-P16 |
Phase III trial has not yet begun recruiting |
Centus Biotherapeutics (AstraZeneca/Fujifilm Kyowa Kirin Biologics joint venture) |
FKB238 |
Phase III trial in progress for NSCLC |
Ligand/Outlook Therapeutics (Oncobiologics) |
ONS-1045 |
Phase III trial for cancer expected to begin in 2019 |
MAbxience SA/Amneal Pharmaceuticals |
BEVZ 92 |
Phase I trial completed for patients with metastatic colorectal cancer |
Pfizer |
Zirabev (bevacizumab-bvzr) |
Approved by FDA June 27, 2019, marketed |
Samsung Bioepis |
SB8 |
351(k) approval for marketing filed November 19, 2019 |
Mylan/Biocon |
MYL-1402O |
351(k) approval for marketing filed December 2019 |
Pfizer’s Intended Launch of Bevacizumab Biosimilar December 31, 2019
(October 1, 2019) After coming to a settlement agreement (which may have been prodded by Amgen’s launch of Mvasi® in July), Pfizer can launch Zirabev® at the end of this year.
Introducing the 21st FDA Approval: Pfizer’s Zirabev, a Biosimilar of Avastin
(June 28, 2019) Pfizer announced that it had received Food and Drug Administration (FDA) approval of Zirabev™ (bevacizumab-bvzr), a biosimilar version of Roche’s Avastin®.
Amgen Withdraws Membership From Biosimilars Advocacy Group
(November 21, 2018) Amgen withdrew in September from The Biosimilars Forum, based on disagreements with the remaining eight biosimilar-manufacturing members and perhaps internal conflicts within Amgen.
Update on Amgen v. Genentech Court Battle Over Mvasi
(August 16, 2018) Genentech and Amgen continued their court fight over technicalities as its ongoing patent litigation is adjudicated in District Court.
Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars
(August 10, 2018) Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.
Court Sets 2020 Trial Date for Amgen v. Genentech in Patent Fight for Mvasi
(April 26, 2018) The District Court hearing the patent litigation between Amgen and Genentech on the latter’s bevacizumab patents issued set a trial date of June 1, 2020.
Fujifilm Gains Further Exposure in Biosimilar Partnerships
(April 12, 2018) Centus Biotherapeutics Limited,is a joint venture between Astra Zeneca and Fujifilm Kyowa Kirin Biologics. Centus seems to be involved only in development of a bevacizumab biosimilar.
Amgen/Allergan Score Positive EMA Evaluation, but Launch Will Be Delayed
(November 13, 2017) Assuming EMA final approval is received, however, Amgen and Allergan’s cancer treatment agent will not be marketed any time soon. The principal European patent is not set to expire until 2022.
Amgen Receives Approval for Bevacizumab Biosimilar
(September 14, 2017) The Food and Drug Administration announced today the approval of the first biosimilar for Roche’s Avastin®. The approval of Mvasi™ (bevacizumab-awwb) represents the first biosimilar approved in the US for the direct treatment of cancer. Amgen is partnered with Allergan in the development and marketing of the new biosimilar.
FDA Advisory Committee Unanimously Recommends Approval for Avastin® and Herceptin® Biosimilars
(July 13, 2017) The Advisory Committee voted 17-0, recommending approval of the drug for all of the originator product’s nonprotected indications.
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