US pharmaceutical giant Amgen has become the first company to seek regulatory approval to sell an Avastin biosimilar in Europe, taking the lead in the race to introduce cheaper replicas of the blockbuster cancer treatment.

Amgen and its partner Allergan announced Saturday that they have submitted ABP 215, a biosimilar referencing Roche’s Avastin (becacizumab) to the European Medicines Agency.

“The companies believe this submission is the first becacizumab biosimilar application submitted to the EMA,” the two companies said in a joint statement.


Amgen and Allergan have submitted the latest clinical trial results to the EMA which proves ABP 215’s pharmacokinetic similarity to the originator drug, they said.

Biosimilars refer to cheaper, near-replicas of cell-based biologic drugs which have lost patent protection. Multiple companies around the world have been developing biosimilars in line with the approaching patent expiry of some of the world’s topselling biologics.

Avastin is currently approved for use by patients with metastatic colorectal cancer, non-small cell lung cancer, metastatic kidney cancer and advanced cervical cancer. The drug generated sales of about $5.1 billion in the first nine months of this year.

In addition to Amgen, Germany’s Boehringer Ingelheim, US pharma company Pfizer and South Korea’s Samsung Bioepis are engaged in a close race to launch their own Avastin biosimilars in Europe.

All three companies are currently conducting phase 3 clinical trials of their self-developed Avastin biosimilars, according to the EU Clinical Trials Register.

Boehringer Ingelheim initiated the final-stage trials of BI 695502 in September 2015 while Pfizer began last-stage trials of PF-06439535 in May 2015.

Trailing behind, Samsung Bioepis began phase 3 trials of SB8 in June 2016. Meanwhile, Biocon and Mylar also began phase 1 trials of its own Avastin biosimilar, MYL-1402O, in July 2016.

By Sohn Ji-young (jys@heraldcorp.com)