Kanjinti

Biosimilar Drug Profile: Kanjinti is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by the partnership of Amgen and Allergan.

Originally designated ABP 980, a biologic license application for approval via the 351(k) biosimilar pathway was initially submitted to the Food and Drug Administration (FDA) in July 2017. A complete response letter was issued by the FDA in June 2018. After refiling for approval later that year, it was approved by the FDA June 13, 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 was launched in the US in July 2019.

Amgen, based in Thousand Oaks, California, is a leading global biotechnology company. The company focuses on six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Partners Amgen and Allergan have two reference products that are currently facing biosimilar competition (filgrastim and pegfilgrastim), but they also have five biosimilars. These include the approved products Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns), and biosimilar infliximab, which has been filed for approval with the FDA. Three products in earlier stages of the pipeline (rituximab, cetuximab, and eculizumab). In addition, Amgen owns the rights to Amjevita (adalimumab-atto).

Allergan and Amgen’s partnership began in 2011 when the latter signed a deal to develop biosimilars with a company (Watson Labs), which was later bought by Actavis, and subsequently became part of Allergan. Most recently, AbbVie, the maker of Humira, announced an agreement to purchase Allergan, which could directly conflict with Amgen’s Amjevita (not co-owned by Allergan).

Trastuzumab Biosimilar(s) Approved and in Development

Currently, at least 6 trastuzumab biosimilars, including Kanjinti, have been reviewed by the FDA. Other than Kanjinti, Ogivri (Mylan/Biocon), Herzuma (Celltrion/Teva), Ontruzant (Samsung Bioepis/Merck), and Trazimera (Pfizer) are the only approved trastuzumab biosimilars to date. All are currently marketed in the US though some were delayed in the US owing to patent issues or licensing deals.

(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) At this week’s GRx+Biosims meeting, two sessions with KP’s executives made it startling clear—if you don’t accept rebates, the decision to move to biosimilars is simple.

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

(July 25, 2019) How does Amgen’s Kanjinti launch affect the licensing agreements that were signed with Roche? Does it mean that Amgen gets a substantial head start on the competition? Do the licensing contracts consider this possibility?

(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) And then there was one. 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) 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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