Eye on Pharma: Celltrion Could Receive EMA Verdict on Trastuzumab in Early 2018

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; according to The Investor, analysts believe that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

Celltrion’s proposed trastuzumab biosimilar is the company’s third biosimilar product pursuing access to the European market, following the launch of Remsima, an infliximab biosimilar of Johnson & Johnson’s reference Remicade, and a rituximab biosimilar, Truxima, referenced on Rituxan.

“Herzuma will be well positioned for Celltrion to have confidence in sales based on 4 years of market experience (in Europe) and a strong partner network,” Park Si-hyeong, an analyst at IBK Securities, told The Investor.

Most recently, the FDA approved Mylan and Biocon's trastuzumab biosimilar, Ogivri. Other Herceptin products in development for the US and EU markets include:

• In the US: Amgen’s ABP 980, filed with the FDA in July 2017 Samsung Bioepis’ Ontruzant, clinical trials are completed Pfizer’s PF-05280014, completing phase 3 clinical trials
• In the EU: Samsung Bioepis’ Ontruzant, approved in November 2017 Amgen’s ABP 980, filed with the EMA in March 2017

In addition to its trastuzumab biosimilar, Celltrion is developing several other notable products:

• CT-P16, biosimilar to bevacizumab, referenced on Avastin
• CT-P05, biosimilar to etanercept, referenced on Enbrel
• CT-P15, biosimilar to cetuximab, referenced on Erbitux (which treates colorectal cancer and some kinds of head and neck cancers)
• CT-P14, biosimilar to palivizumab, referenced on Synagis (which prevents serious lower respiratory tract disease caused by respiratory syncytial virus in infants and children)
• CT-P17, biosimilar to adalimumab, referenced on Humira

The Investor reports that an official at Celltrion has indicated that Herzuma will be able to hit the European market 3 months after approval. Celltrion has not decided yet on its marketing partner for the drug, but it is likely to continue to work with existing partners such as Mundipharma, Biogaran, and Kern Pharma.