Brexit could become a headache for export-driven South Korean biopharmaceutical companies as they may be required to go through separate processes to obtain sales approvals and handle litigation issues both in Britain and Europe, regarded as their biggest overseas market destinations.

According to local reports, industry watchers have suggested that Britain’s departure from the European Union could mean an exit from the European Medicines Agency, the European version of the U.S. Food and Drug Administration.

In such a case, drugmakers seeking entry into the U.K. market would need to shift their European export strategy from the initial approval stage to marketing and commercialization.

Others have raised concerns that legal decisions made in the U.K. courts will not be honored by other EU member states as is the case now, creating new legal hurdles for entering the region’s markets.

Samsung Bioepis said it is in contact with the EMA over potential changes that may come about from Brexit, though it is too early to deduce any clear conclusions.

“We are currently discussing this issue with the EMA and are considering a wide range of options, given there are at least two years left (until Britain concludes its departure),” Samsung Bioepis vice president Park Sung-won told The Korea Herald.

“Once a guideline of some form is set up, we will take action accordingly,” he said.

As for its ongoing lawsuit against U.S.-based AbbVie in the U.K., the Samsung VP said their legal team is currently at work and the company will have to “wait for new developments.”

Celltrion, meanwhile, dismissed all concerns related to Brexit.

“Brexit won‘t negatively impact our company or the Korean biopharma industry. There is very little chance that the U.K. will severe its business-related ties with the EU, including its inclusion in the EMA,” said Celltrion’s public relations director Yoo Byung-sam.

The Celltrion executive also pointed out that the U.K. is a member of the European Patent Convention -- an autonomous, pan-European body independent from EU affairs.

“In the case of Norway and Iceland, they are not a part of the EU, but are members to the EMA and the European Patent Convention,” Yoo said, suggesting the U.K. could head down a similar path.

Samsung Bioepis and Celltrion currently sell a number of biosimilars in the EU, including in the U.K. under certification by the EMA. Biosimilars refer to near-replicas of biologic drugs that have lost patent protection.

Celltrion’s Remicade (infliximab) biosimilar was approved by the EMA in August 2013 and commercialized in Europe in February 2015. Samsung Bioepis’ Enbrel (etanercept) biosimilar was granted EMA approval in January and has since begun sales in the region. Its Remicade biosimilar was approved by the EMA last month as well.

Both companies have several more biosimilars referencing major drugs such as Herceptin (trastuzumab), Humira (adalimumab) and Rituxan (rituximab) set for submission to the EMA and commercialization in the future.

As of now, the two drugmakers are engaged in lawsuits challenging a number of patents held by the original drugmakers in the U.K. as well. Samsung Bioepis has filed a patent suit against AbbVie while Celltrion is engaged in a suit against Biogen, Roche and Genentech over their patents on Rituxan.

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