Trazimera

Summary: Trazimera is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Pfizer.

Originally designated PF-05280014 , a biologic license application for approval via the 351(k) biosimilar pathway was initially submitted to the Food and Drug Administration (FDA) in the third quarter of 2017. A complete response letter was issued by the FDA in April 2018, citing the need for additional technical information (not additional clinical studies). After refiling for approval later that year, it was approved by the FDA March 11, 2019 (without requiring evaluation by the FDA’s Oncology Drug Advisory Committee). This agent was approved for both of the indications held by the reference product (approved to treat HER-positive breast cancer and to treat HER-positive gastric cancer). The drug launched in February 2020 the US.

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 Nivestym, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; and Retacrit, a biosimilar epoetin that was approved in May 2018. Pfizer’s biosimilar pipeline consists of a biosimilar trastuzumab, bevacizumab, and rituximab, all being filed for approval with the FDA; biosimilar adalimumab in phase 3 trials; and biosimilar pegfilgrastim in phase 1 development.

Trastuzumab Biosimilar(s) Approved and in Development

Currently, 5 trastuzumab biosimilars, including Trazimera, have been approved by the FDA. All have launched, with Merck/Samsung Bioepis’ Ontruzant being the most recent (April 2020). Patent issues and licensing agreements with Genentech (Roche) have significantly delayed launch of biosimilars to the reference product (Herceptin).

(January 20, 2021) The company has completed phase 3 trials for its trastuzumab biosimilar has applied for approval in the European Union. A 351(k) filing in the United States may also happen this year.

(April 15, 2020) This morning, Merck issued a press statement to announce that it had joined the trastuzumab biosimilar fray, with the launch of Ontruzant^®, which was developed by its partner Samsung Bioepis.

(March 17, 2020) Approved in 2018, Herzuma^® is hitting the market, announced Teva and Celltrion. Teva, which is marketing the trastuzumab biosimilar in the US and Canada, will begin offering the biosimilar at a wholesale acquisition cost (WAC) of 10% below that of the reference biologic Herceptin^®.

(January 27, 2020) Activity on Pfizer’s biosimilar front has been electric over the past couple of months, as it executes its launch plan for three biosimilar monoclonal antibodies to treat cancer.

(December 2, 2019) Amgen now has company as the second biosimilar competitor to Herceptin^® has launched. On December 2, 2019, Mylan and Biocon announced the availability of Ogivri in the United States.

(November 7, 2019) The secret is in the sauce that makes Kaiser Permanente a truly integrated payer, and in its devout avoidance of the Achilles heel of other payers.

(October 30, 2019) The New York–based pharmaceutical manufacturer plans to begin marketing Ruxience in January 2020, and Trazimera February 15, 2020.

(March 11, 2019) Pfizer announced that it received approval of its trastuzumab-qyyp on March 11. Dubbed Trazimera, it is the fourth approved Herceptin biosimilar. No word was provided on when it would enter the market.

(January 18, 2019) This is the third trastuzumab biosimilar approved by the FDA, following those by Mylan and Biocon in December 2017 (Ogivri^®) and Teva and Celltrion last month (Herzuma).

(December 14, 2018) The US Food and Drug Administration gave its approval for a new trastuzumab biosimilar (Herzuma™). Manufactured by Celltrion and marketed in the US by Teva, this agent has been designated trastuzumab-pkrb.

(December 10, 2018) Pfizer joined Mylan/Biocon in signing a confidential licensing agreement with Roche that cancels any patent litigation between the companies but delays launch.

(August 9, 2018) In reporting lower earnings on its second-quarter revenues, Mylan may have surprised industry observers by offering the possibility of some changes in strategic direction.

(June 3, 2018) Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab. On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin^® biosimilar.

(May 18, 2018) A presentation at the annual American Society of Clinical Oncology (ASCO) meeting promised equal efficacy and much improved safety for patients with early-stage breast cancer receiving a 6-month instead of 12-month regimen of trastuzumab^®.

(April 24, 2018) When Pfizer announced that it received a complete response letter from the Food and Drug Administration (FDA), the wait for an available biosimilar to Herceptin^®just got longer..

(April 5, 2018) Celltrion and its partner Teva were dealt a significant blow today, as the Korean manufacturer announced that the latest two biosimilar candidates were rejected by the Food and Drug Administration.

(December 3, 2017) On December 1, the team of Mylan and Biocon received their first biosimilar approval in the US, for an agent to compete with Roche’s Herceptin^®. The approval decision on this product was delayed 3 months owing to potential issues involving Biocon’s manufacturing facility. However, this marks the first biosimilar approved for trastuzumab, beating entries from Amgen/Allergan and Celltrion to the 351(k) finish line.

(March 3, 2017) A settlement reached with Genentech and F. Hoffmann-La Roche Ltd. should allow Mylan to launch its biosimilar version of Herceptin^® soon after the completion of its Food and Drug Administration (FDA) review in September.

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