[THE INVESTOR] Korea’s biosimilar maker Celltrion has denied a news report that its proposed biosimilar of Herceptin could face delayed European approval due to late data submission.

The European Medicines Agency found no lapses during a pre-approval inspection of Celltrion’s product site and drug substance Herzuma, the firm’s copy version of Roche’s blockbuster breast cancer med, according to the company on Aug. 21. It also managed to hand in the documents that the company was required to provide after inspection. 

“We don’t expect any major changes in approval procedures although the inspection date had been pushed back a little because of differing schedules,” a Celltrion official told The Investor.

A local news outlet on Aug. 20 reported that the EMA could postpone approval of Herzuma to 2018 from originally expected this year as the company failed to submit documents on time.

Given that the EMA typically takes just over a year to approve a drug, Celltrion is expected to get the green light to sell Herzuma this autumn as it filed the application in October last year.

Any delays in approval procedures for Herceptin biosimilar candidates could have an impact on other drug makers eyeing the US$2 billion EU market for the original drug including Samsung Bioepis, which filed for EU approval in September.

The biosimilar industry is closely watching which Korean firm will win the race to be first with a copy as India’s Biocon, which was expected to hit the EU market first, withdrew its application due to production facility issues last week.

With global sales of around US$7 billion a year, Herceptin is one of a trio of big-selling Roche drugs.

By Park Han-na (hnpark@heraldcorp.com)