Dan Stanton, Managing editor

March 13, 2019

2 Min Read
Pfizer’s trastuzumab becomes US biosimilar number 18
Image: iStock/chatsimo

The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab).

Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past three months Celltrion and Samsung Bioepis/Merck & Co. have seen regulatory success with their respective trastuzumab programs.


Image: iStock/chatsimo

So far none of these trastuzumab biosimilars have launched in the US and Roche’s monopoly remains unthreatened. In 2018, the MAb pulled in CHF 2.9 billion ($2.9 billion) in US sales for the Swiss biopharma firm.

“Pfizer is working to make Trazimera available to patients as soon as possible,” Pfizer spokesperson Jessica Smith told BioProcess Insider. When asked, Smith was unable to offer further details regarding launch, specific pricing or commercialization strategies.

“However, by introducing biosimilars like Trazimera to the US market, Pfizer hopes that patients and their physicians will have improved access to a high-quality, potentially lower-cost alternative trastuzumab treatment option within its approved indications.”

US biosimilars by numbers

Trazimera is Pfizer’s fifth biosimilar to be approved by the FDA and its first biosimilar MAb.

It is the eighteenth biosimilar to be granted approval and the fourth trastuzumab biosimilar.

The full list is as follows:

  1. March 2015: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen

  2. April 2016: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade

  3. August 2016: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel

  4. September 2016: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira

  5. April 2017: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade

  6. August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira

  7. September 2017: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin

  8. December 2017: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin

  9. December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade

  10. May 2018: Pfizer’s Retacrit (epoetin alfa-epbx), a version of Amgen’s Epogen and Procrit

  11. June 2018: Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), a version of Amgen’s Neulasta

  12. July 2018: Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen

  13. Oct 2018: Sandoz’s Hyrimoz (adalimumab-adaz), a biosimilar to AbbVie’s Humira

  14. Nov 2018: Coherus’s Udenyca (pegfilgrastim-cbqv), a version of Amgen’s Neulasta

  15. Nov 2018: Celltrion’s Truxima (rituximab-abbs), a version of Roche’s Rituxan

  16. Dec 2018: Celltrion’s Herzuma (trastuzumab-pkrb), a version of Roche’s Herceptin

  17. Jan 2019: Bioepis/Merck’s Ontruzant (trastuzumab-dttb), a version of Roche’s Herceptin

  18. Mar 2019: Pfizer’s Trazimera (trastuzumab-qyyp), a version of Roche’s Herceptin

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.

Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.

From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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