Korean biotech firm Samsung Bioepis is expected to take the lead in the race to get a copycat version of Roche’s Herceptin to market in Europe, as India’s Biocon withdrew its filing.
Biocon, which had expected to be first to market in the EU with a copy of the blockbuster breast cancer drug, said on Aug. 16 that it would withdraw its application after the European Medicines Agency told the company it would need to re-inspect a drug production facility.
The withdrawal is a boon for other drugmakers rushing to be first with a copy. Especially, Samsung Bioepis, which was only weeks behind in applying for its version SB3 to the European drug regulator in September in 2016. “All we can say is that we are on track to gain EMA approval,” a Samsung Bioepis official told The Investor.
Holding “first mover advantage” is critical for biosimilar makers to establish market share amid fierce competition.
The US$2 billion EU market for Herceptin could become a new battlefield for Samsung Bioepis and its cross-town rival Celltrion, which filed for approval of its own Herceptin copy, Herzuma, in October last year.
The two Korean companies are expected to get green light to sell their biosimilar versions this autumn, as the EMA typically takes just over a year to approve a drug.
Apart from Herceptin, there is a lot of overlap between the two companies’ drug portfolios, including biosimilar versions of the world’s top selling branded therapies -- Enbrel, Remicade, Humira, Avastin and Rixutan.
Meanwhile, Biocon said it would seek resubmission next quarter while Allergan and Amgen filed for EU approval of their Herceptin biosimilars in March.
By Park Han-na (firstname.lastname@example.org