Celltrion is one of only a handful of successful biosimilar developers in the US having seen its version of J&J’s Remicade (infliximab), Inflectra, approved by the US Food and Drug Administration (FDA) and commercialised through its partnership with Pfizer.
But the South Korean manufacturer is now looking to enter the US generics market, spokesperson Gunhyuk Lee confirmed to this publication.
“Celltrion Pharm has been preparing [its] generic manufacturing and [was] just inspected by FDA,” he told us.
“This is the first case and first venture with generic drugs into the US market for Celltrion Pharm.”
Lee was unable to disclose further information regarding the type of generic Celltrion was looking to bring to the US, or any details of potential partners.
The facility visited by FDA inspectors is a chemical pharmaceutical production plant in Ochang, North Chungcheong Province, about 100km east of the firm’s FDA approved biomanufacturing plants in Songdo, Incheon.
The site, which received cGMP approval from Korean regulators MFDS in 2015, makes over 10 billion tablets for vascular, mental and digestive diseases per year, according to Lee, with extra space available. The 38,440m2 space employs close to 600 staff.
If successful, Celltrion would become the latest Korean small molecule generic firm to enter the US. Earlier this year, Daewong launched a version of AstraZeneca’s antibiotic Merrem (meropenem), making it the first Korean generic in the US.
Meanwhile, in July fellow Korean drugmaker Huons received FDA approval to supply sodium chloride injection (0.9%).