Ontruzant

Biosimilar Drug Profile: Ontruzant is an FDA-approved biosimilar version of traztuzumab (reference product, Herceptin, Roche).

Originally known as SB3, Samsung/Bioepsis submitted a biologic license application for approval via the 351(k) biosimilar pathway in December 2017. The Food and Drug Administration (FDA) approved the biosimilar on January 21, 2019. The drug was launched in the US in April 2020; Merck is the US marketer for the product . The European Medicines Agency approved Ontruzant for use in the EU in November 2017 and is available in several European countries.

Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen that operates as a subsidiary of Samsung Biologics Co., Ltd.  In Early 2013 Samsung Bioepsis and Merck entered into a business agreement to develop and commercialize biosimilars. Samsung Bioepis Co., Ltd. also entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited in August 2017. The company was incorporated in 2012 and is based in Incheon, South Korea.

In addition to Ontruzant, Samsung Bioepsis also holds an FDA approval for Renflexis (an infliximab biosimilar), Hadlima (an adalimumab biosimilar), Eticovo (an etanercept biosimilar), and Lusduna (a 505b2 approval for a follow-on biologic version of insulin glargine). The company is also seeking approval of biosimilars for ranibizumab and eculizumab.

Ontruzant was the third trastuzumab biosimilar to be approved by the FDA. It was the fifth biosimilar to Herceptin launched on the US market. Several had signed licensing agreements with Roche, which delayed their launches. Amgen’s Kanjinti, Mylan/Biocon’s Ogivri, Pfizer’s Trazimera, and Mylan/Biocon’s Herzuma have all launched.

(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) Pfizer enters a more crowded marketplace with the upcoming launch of Trazimera. Both Kanjinti^® and Ogivri^® have been launched, the latter being made available in December 2019 at a 13% ASP discount to Herceptin.

(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) 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.

(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 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) The fourth biosimilar (Trazimera) was approved by the FDA. Dubbed trastuzumab-qyyp) it will compete for the Herceptin market at some point in the future.

(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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