EC OKs Pfizer’s Biosimilar of Roche’s Blockbuster Drug HerceptinBy
The European Commission (EC) has approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin (trastuzumab), for treating certain types of breast and gastric cancers. Herceptin had global 2017 sales of CHF 7.01 billion ($7.5 billion).
Specifically, Pfizer received approval for its biosimilar for treating human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Trazimera is Pfizer’s fourth biosimilar to receive European approval. Pfizer’s biosimilars pipeline consists of nine Pfizer and legacy Hospira biosimilar molecules in various stages of development. In addition to its internally developed biosimilars portfolio, Pfizer gained a biosimilars portfolio through its $17 billion acquisition of Hospira in 2015.
Pfizer’s application for its trastuzumab biosimilar is still pending in the US. In April 2018, the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Pfizer in response to the company’s biologics license application (BLA) for it Herceptin biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The additional requested information did not relate to safety or clinical data.
Other companies are advancing Herceptin biosimilars. In December 2017, the FDA approved Ogivri (trastuzumab-dkst), a biosimilar of Herceptin, from Mylan and Biocon, a Bangalore, India-based pharmaceutical company. Ogivri was approved for all indications included in the label of Herceptin, including for treating HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Additionally, Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based life-sciences company, are progressing a Herceptin biosimilar, and recently resubmitted its BLA for its Herceptin biosimilar following the issuance of a CRL by the FDA. Celltrion and Teva formed an exclusive partnership to commercialize two biosimilars (a biosimilar of Roche’s Herceptin and Rituxan (rituximab)) in the US and Canada in 2016.
Celltrion submitted its original BLAs for its biosimilar to Roche’s Herceptin and to its second biosimilar candidate that referenced Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases. In April and May of 2017, but it later received in April 2018 a CRL from the FDA over manufacturing issues. The CRL followed the issuance of a Warning Letter by the FDA to Celltrion in January 2018 for violations of good manufacturing practices for finished pharmaceuticals. The FDA subsequently notified Celltrion of a reinspection of the facilities, and Celltrion resubmitted its BLAs for its Herceptin biosimilar in June 2018 and for its Rituxan biosimilar in May 2018.
Amgen and Allergan, which formed a pact in 2011, to develop biosimilars, are also advancing a Herceptin biosimilar, however, in June 2018, the FDA issued a CRL to Amgen regarding its BLA for its biosimilar to Roche’s Herceptin.