Kanjinti

Product Profile:

Trastuzumab-anns (Kanjinti)

Drug Category: HER2/neu receptor antagonist

Target Indications: Treatment of HER2-overexpressing breast cancer (adjuvant treatment, nonmetastatic; primary treatment, metastatic breast cancer) and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

Developed by Amgen and Allergan; marketed by Amgen

Summary: 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.

About the Manufacturer

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).

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

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. Kanjinti and Ogivri are the only trastuzumab biosimilars currently marketed in the US; others have been delayed in the US owing to patent issues or licensing deals.

APPROVED TRASTUZUMAB BIOSIMILARS

Company Name

Brand name

When Filed

Approval Date/Marketing Status

Mylan/Biocon

Ogivri

November 2016

December 2017; marketed

Celltrion/Teva

Herzuma

July 2017/June 2018

December 2018; not yet marketed

Samsung Bioepis/Merck

Ontruzant

December 2017

January 2019; not yet marketed

Pfizer

Trazumera

Q3 2017

March 2019; not yet marketed

Amgen/Allergan

Kanjinti

July 2017/June 2018

June 2019; marketed

Partners Mylan and Biocon Announce Launch of Trastuzumab Biosimilar Ogivri

(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.

How Did Kaiser Permanente Reach 95%+ Utilization of Biosimilar Herceptin and Avastin so Quickly?

(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.

Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars

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

The Potential Effect of Amgen’s Launch on Biosimilar Licensing Deals

(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?

Amgen/Allergan Partners Announce Launches of Herceptin and Avastin Biosimilars

(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.

Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar

(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.

Amgen/Allergan Announce FDA Approval of Their Trastuzumab 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.

Pfizer Gains Approval for Trazimera, Its Trastuzumab Biosimilar

(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.

Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzuma

(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).

Second Trastuzumab Biosimilar Approved, Herzuma by Celltrion

(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.

Pfizer Signs Licensing Agreement with Roche on Trastuzumab Biosimilar

(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.

Mylan Rethinking Its US Business Strategy?

(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.

FDA Approval Eludes Amgen for Biosimilar Trastuzumab

(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.

Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?

(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®.

Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan

(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..

Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars

(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.

Mylan/Biocon Receive First Approval for Trastuzumab Biosimilar, but First to Market?

(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.

Mylan Clears the Way to Potential Trastuzumab Biosimilar Launch

(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.

What Is HER2-Positive Breast Cancer?

The Basics of Biosimilars

Clinical Trials of Kanjinti

Phase 3 Trial

Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial

In this study conducted with patients from 20 countries, outcomes with Kanjinti (ABP 980) were compared with those for Herceptin in women with HER2-positive early breast cancer. All patients had a confirmed diagnosis, and an

Eastern Cooperative Oncology Group performance status score of 0 or 1. All patients were planning to undergo surgical dissection and receive neoadjuvant chemotherapy.

Each woman received four cycles of anthracycline-based chemotherapy, after which they were randomized to receive either ABP 980 or EU-licensed reference trastuzumab. After an 8-mg/kg loading dose of the biosimilar or reference product in addition to paclitaxel 175 mg/m2, each study participant received up to three cycles of 6 mg/kg ABP 980 or trastuzumab plus paclitaxel 175 mg/m2 every three weeks (or 12 cycles of paclitaxel 80 mg/m2 once weekly). Surgery, which was completed three to seven weeks after the last dose of neoadjuvant treatment, was followed by adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year after the patient’s initial dose. At this point, patients were randomized to continue receiving APB 980 or trastuzumab, or switch from the reference product to the biosimilar during the adjuvant treatment phase.

The trial’s primary outcome endpoints were risk difference and risk ratio (RR) of pathological complete response in patients who were received any of the neoadjuvant therapy and had surgical resection.

In the neoadjuvant phase, 725 patients were randomly assigned to receive ABP 980 (n=364) or Herceptin (n=361). The primary endpoint was assessable in 696 patients (358 who received ABP 980 and 338 who received trastuzumab). The key results for the central laboratory-assessed tissue samples are shown below in the Table:

Parameter

ABP 980 (Kanjinti)
(n = 358)

EU-licensed Herceptin
(n= 338)

Pathologic complete response

48%

42%

≥ Grade 3 adverse events (neoadjuvant phase)

15%

14%

≥ Grade 3 adverse events (adjuvant phase)

9%

6%

These results indicate a RR of 1.14 in favor of the biosimilar. (Note: the 95% confidence interval exceeded the predetermined equivalence margins of 1.318 for RR.) Additionally, in the adjuvant phase, grade 3 or worse adverse events occurred in 8% of 171 patients who switched therapy to ABP 980.

The researchers found that ABP 980 was at least noninferior to EU-licensed Herceptin in terms of efficacy, with comparable safety metrics during both the neoadjuvant and adjuvant phases of the study.

Phase 1 Studies

A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects.

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