In two separate moves, Teva Pharmaceutical Industries, Celltrion, an Incheon, Korea-based life-sciences company, Amgen, and Allergan have advanced their respective filings for biosimilar candidates to Roche’s cancer drug, Herceptin (trastuzumab). Herceptin, approved in the US for treating HER2-positive adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer, is a top-selling drug for Roche with 2016 sales of CHF 6.78 billion ($7.04 billion).

In the first move, the US Food and Drug Administration (FDA) has accepted for review a biologics license application (BLA) for a biosimilar candidate (CT-P6) to Herceptin from Teva Pharmaceutical Industries and Celltrion. In another move, Amgen and Allergan’s submitted to the FDA a BLA for ABP 980, their biosimilar candidate to Herceptin.

Teva’s and Cellitron’s CT-P6 is used for treating HER2 breast cancer and metastatic gastric cancer.  CT-P6 has been approved by the Korean Ministry of Food and Drug Safety. Celltrion also filed marketing authorization applications for CT-P6 to the European Medicines Agency in October 2016.

Teva is Celltrion’s North American commercial partner for CT-P6 as well as CT-P10, a proposed biosimilar to Roche’s Rituxan/MabThera (rituximab), a drug to treat certain cancers and autoimmune diseases. MabThera/Rituxan is Roche’s top-selling drug with 2016 sales of CHF 7.3 billion ($7.48 billion).  

Celltrion and Teva entered into an exclusive partnership to commercialize CT-P6 and CT-P10 in the US and Canada in October 2016. The BLAs for both CT-P6 and CT-P10 have been accepted for filing by the FDA for standard review with the FDA regulatory action expected during the first half of 2018. CT-P10 was approved by the European Commission in February 2017 and has been launched in the UK, Germany, the Netherlands, Spain, and the Republic of Korea. The FDA also accepted for review the BLA for CT-P10 in June 2017.

Amgen’s and Allergan’s, biosimilar candidate to Roche’s Herceptin is one of four oncology biosimilars being developed by Amgen and Allergan. In December 2011, Amgen and Allergan (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize four oncology antibody biosimilars on a worldwide basis. Under the agreement, Amgen assumes primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.

Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the FDA. In September 2016, Amgen received FDA approval for Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab), AbbVie’s anti-tumor necrosis factor (TNF) for treating various inflammatory diseases. Humira was AbbVie’s top selling drug in 2016 with global sales of $16.08 billion.

Source: Teva Pharmaceutical Industries and Amgen