Herzuma

Biosimilar Drug Profile:  Herzuma is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Celltrion.

Originally designated CT-P6, 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, regarding manufacturing plant problems. Celltrion refiled for approval in June 2018, and it was approved by the FDA December 14, 2018 (without requiring evaluation by the FDA’s Oncology Drug Advisory Committee). This agent was approved for one of the two indications held by the reference product (approved to treat HER-positive breast cancer, not to treat HER-positive gastric cancer). The drug was launched in the US in March 2020; by Teva, who has marketing rights in in North America. In the EU, Celltrion received approval in February 2018.

Celltrion was founded in 2002 in Incheon, South Korea. Its first biosimilar product was approved in 2013 by the European Medicines Agency. Inflectra was first approved in the US in 2016. Another biosimilar product (Truxima) was approved in November 2018, and Celltrion has several other biosimilar products in development. Celltrion and Teva partnered on two approved cancer-treating biosimilars (Truxima and Herzuma). It is partnered with Pfizer on its other approved biosimilar Inflectra (for treating autoimmune disease).

In addition, Celltrion’s pipeline includes several products at various stages of development, including adalimumab, bevacizumab, cetuximab, etanercept, palivizumab, and a subcutaneous formulation of Inflectra.

Herzuma was the second trastuzumab biosimilar to be approved by the FDA. The product was launched in March 2020.

Trastuzumab Biosimilar(s) Approved and in Development

Currently, 5 trastuzumab biosimilars, including Herzuma, have been reviewed by the FDA. Ogivri (Mylan/Biocon), Herzuma (Celltrion/Teva), Ontruzant (Samsung Bioepis/Merck), Kanjinti (Amben), and Trazimera (Pfizer) are the only approved trastuzumab biosimilars to date. Kanjinti and Ogivri launched in the summer of 2019, Pfizer launched Trazimera in February 2020, and Teva launched Herzuma one month later.  As of April 2020, all FDA-approved trastuzumab biosimilars have been launched and available for prescription, though several were delayed 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.

(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 Kaiser Permanente’s executives made it startling clear—if you don’t accept rebates, the decision to move to biosimilars is simple.

(October 30, 2019) At an earnings call this week, Pfizer’s CEO highlighted the impending launches of Ruxience^® and Trazimera^®, not long after the previously announced launch of Zirabev^® (bevacizumab) at the end of this year.

(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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