Biosimilar Drug Profile:  Ogivri is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed and manufactured by the team of Biocon and Mylan (now known as Viatris).

A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in November 2016. It received a unanimous recommendation for approval from the FDA’s Oncology Drug Advisory Committee; formal approval was received December 3, 2017. The drug was launched in the US in December 2019, delayed because of a licensing agreement Mylan signed with Roche.

The partners Mylan and Biocon are very active in the biosimilar space. Mylan is a US-based company that focuses on generics and specialty pharmaceuticals. Biocon is an Indian pharmaceutical company thatmanufactures and commercializes complex generics, biosimilars, insulins, and novel biologics. Their global partnership in biosimilars includes the approved products Ogivri and the pegfilgrastim biosimilar Fulphila, in addition to nine other biosimilars and insulin agents (not all of these agents will be targeted for US FDA approval).

Ogivri was the first of five trastuzumab biosimilars to be approved by the FDA. All of these products have now been launched (as of April 2020).

Trastuzumab Biosimilar(s) on the Market

Currently, 6 trastuzumab biosimilars have been reviewed by the FDA. Ogivri (Mylan/Biocon), Herzuma (Celltrion/Teva), Ontruzant (Samsung Bioepis/Merck), Trazimera (Pfizer), and Kanjinti (Amgen) have been approved to date.

(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.

(July 19, 2019) Amgen has announced 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.

(July 12, 2019) Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant^®, an approved Herceptin^® biosimilar.

(June 17, 2019) According to Goodwin’s Big Molecule Watch, Roche’s infringement claims against Samsung Bioepis (Ontrusant^®) and Amgen/Allergan (Kanjinti^®) are still being litigated. For Genentech v. Samsung, the bench trial is slated to begin December 9, 2019.

(June 14, 2019) On June 13, the Food and Drug Administration (FDA) approved the fifth trastuzumab biosimilar. This product, Kanjinti (trastuzumab-anns), will be produced through the partnership of Amgen and Allergan.

(March 11, 2019) A fourth trastuzumab biosimilar has been approved by the US Food and Drug Administration (FDA). Pfizer’s biosimilar version of trastuzumab-qyyp (Trazimera) gained approval on March 11.

(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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