Celltrion's drive remains relentless despite being joined on 'lonely path' by host of biosimilar manufacturers

It was no fluke when Celltrion Healthcare (Kosdaq: 068270) became the first drug developer to win approval for a biosimilar monoclonal antibody (MAb) from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) with its copy of Remicade (infliximab).

The first approval for that product, Remsima, came in Celltrion’s native Korea in 2012, and while it marked the start of the opening up of the MAb biosimilar market that other players have since entered, before then this field was a “difficult and lonely” path, chief executive Woo Sung Kee has said.

There was huge capital and technical expertise needed to copy biologic drugs, unlike producing generic copies, and Celltrion was the first to walk this path.