Zirabev

Summary: Zirabev is a biosimilar version of bevacizumab (reference product, Avastin) manufactured by Genentech (a subsidiary of Roche). It was approved on June 28, 2019 and was the second bevacizumab biosimilar approved by the FDA (Mvasi was approved in September 2017).

The biosimilar was originally designated PF-06439535.  A biologic license application for its approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in August 2018. The FDA approved Zirabev with extrapolation to all of Avastin’s indications, except for ovarian cancer.

Zirabev was first marketed in the US in January 2020, joining Mvasi, which Amgen began to market Mvasi in July 2019.

Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. In addition to Zirabev, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; Trazimera, a biosimilar trastuzumab; Retacrit, a biosimilar epoetin that was approved in May 2018; Ruxience, a biosimilar rituximab that was approved in July 2018; and Nevistym, a biosimilar version of filgrastim that is also marketed. Pfizer’s biosimilar pipeline consists of a biosimilar adalimumab in phase 3 trials; and biosimilar pegfilgrastim in phase 1 development.

Mvasi is the first bevacizumab biosimilar to be approved by the FDA. The product entered the marketplace in July 2019. Pfizer’s Zirabev launched in December 2019. This chart represents bevacizumab biosimilars still in development. 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.

(January 27, 2020) At Pfizer’s stated pricing of $61.34 for a 10-mg vial, this represents a 23% discount to the reference product’s wholesale acquisition cost. It also represents a 12% discount to Avastin’s average sales price ([ASP] defined as the price after discounts and rebates).

(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.

(July 19, 2019) The partnership of Amgen and Allergan made a huge splash in the biosimilar market by announcing the simultaneous US launches of the first two biosimilars of anticancer monoclonal antibodies. The agents Kanjinta^® (trastuzumab-anns) and Mvasi^® (bevacizumab-awwb) were officially made available July 18.

(June 28, 2019) On 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^®.

(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.

(August 16, 2018)  Genentech and Amgen continued their court fight over technicalities as its ongoing patent litigation is adjudicated in District Court.

(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.

(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.

(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.

(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.

(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.

(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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