U.S.-based pharmaceutical giant Amgen has withdrawn its patent infringement suit against biosimilar developer Samsung Bioepis in Canada, clearing the way for the Korean drugmaker’s entry into the North American market.

Last month, Amgen Canada withdrew its prohibition order request on Brenzys, Samsung’s biosimilar replication of Amgen’s original blockbuster rheumatoid arthritis treatment Enbrel (etanercept), according to Samsung Bioepis on Wednesday.



In May 2015, Samsung Bioepis had submitted an approval request to the Canadian health authorities to begin selling its Enbrel biosimilar in the country. Biosimilars refer to cheaper, near-replicas of brand-name biologic drugs that have lost patent protection.

In July, Amgen had filed a claim against Samsung’s new biosimilar drug, accusing the Korean drugmaker for breaching two formulation patents on Enbrel. Amgen’s independent patent on Enbrel’s base ingredient etanercept expired last year.

Samsung Bioepis had counteracted Amgen‘s accusation, regarding the issue as a common tactic brought by the original drugmaker.

“Patent suits by original drugmakers are common when a biosimilar drug seeks to gain approval in new overseas markets,” said a Samsung spokesperson in a previous interview.

With Amgen stepping back, Canada’s medicines agency is set to resume reviewing Brenzys as planned. If approved, the Korean drug maker is expected to debut the new drug in the North American country.

Meanwhile, Samsung Bioepis’ new drug obtained official sales approval in Europe in January this year, becoming the first Enbrel biosimilar ever to be approved in the region.

Samsung’s drug -- sold as Benepali in Europe -- is set to infiltrate the market dominated by the original Enbrel. The size of the market is estimated at $2.5 billion.

Benepali has already begun sales in Norway. Samsung also has been preparing for market entry in other European countries.

In addition to Benepali, Samsung Bioepis’ Remicade (infliximab) biosimilar SB2 is also expected to enter European markets in the near future as it awaits final approval from the EMA.

Established in 2012, Samsung Bioepis is an affiliate of Samsung Group specializing in biosimilars development, formed as a joint venture between Samsung BioLogics and U.S.-based Biogen.

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