celltrion1

Celltrion’s Herceptin biosimilar seals EU approval

pharmafile | February 15, 2018 | News story | Sales and Marketing EU, Europe, Herceptin, Herzuma, celltrion, pharma 

Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has revealed.

The drug has been authorised in all of its reference product’s approved indications, which includes early breast cancer, metastatic breast cancer, or metastatic gastric cancer in patients whose tumours have either HER2 overexpression or HER2 gene amplification.

The decision marks the third approval for a Celltrion biosimilar by the European Commission, and follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) at the end of last year. The drug is currently awaiting a regulatory decision in the US.

“The development of biosimilar is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patients’ accessibility to innovative drugs at a more affordable price,” said Woosung Kee, Chief Executive Officer of Celltrion. “We have already seen many benefits of biosimilars in Europe from our experience with Remsima and Truxima. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.”

Matt Fellows

Related Content

GSK’s Jemperli approved in EU as treatment for endometrial cancer

GSK has announced that the European Commission (EC) has granted marketing authorisation to Jemperli (dostarlimab) …

Daiichi Sankyo’s Vanflyta approved by EC for acute myeloid leukaemia treatment

Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination …

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Latest content