Samsung's 1st biosimilar drug approved

Samsung Group, South Korea's leading conglomerate, has taken a significant step toward driving forward its newly-established biopharmaceuticals business, an emerging sector expected to become one of the company's future growth engines.

Samsung Bioepis, the conglomerate's biotechnology research and development unit, said Monday that it had gained approval from the Ministry of Food and Drug Safety to begin selling Brenzys, its biosimilar copy of Pfizer's rheumatoid arthritis treatment Enbrel, in South Korea.

"Samsung Bioepis has received its first product approval since the company was founded 3 1/2 years ago. We are happy that our product's value has been recognised by the Ministry of Food and Drug Safety as well as various international academic circles," said Samsung Bioepis CEO Ko Han-sung.

The achievement marks a milestone for Samsung's biopharma business, which kicked off in May 2010 with the establishment of Samsung Biologics -- the owner of Bioepis and a contract manufacturer for global pharma firms.

Brenzys is set to enter the domestic pharmaceuticals market as early as the end of this year after prices are determined by the Health Ministry, the company said.

US-based health care company MSD Korea, which entered a marketing partnership with Samsung Bioepis in 2013, will handle the new drug's domestic marketing and sales.

The new biosimilar was developed through multiple clinical trials in 11 countries around the globe, Samsung said, adding that the drug's effectiveness and value was recently recognised and highlighted by the European League Against Rheumatism in June.

Biosimilars -- forecast to form a global multibillion-dollar industry in the years to come -- are lower-cost copies of expensive biologic drugs that have lost patent protection. Composed of living cells and naturally occurring proteins, biologics are usually more difficult to develop and replicate than conventional chemical-based drugs.

Eyeing new business opportunities, companies like Samsung, LG and Celltrion -- an early pioneer in the field of biotech medicine in Korea -- have been actively pursuing the development and commercialization of biosimilars.

Samsung Bioepis is currently working on developing and commercializing biosimilar copies of six blockbuster biologic drugs developed by global pharmaceutical firms -- Enbrel, Remicade, Humira, Herceptin, Avastin and Lantus -- in line with their approaching patent expiration dates.

Biosimilar copies of rheumatic disease treatments Enbrel and Remicade are currently under review for commercialization in Europe and the United States, the Samsung subsidiary said. The company is also looking to commercialize its Humira biosimilar in the near future, which successfully passed through the three required phases of clinical tests last month.

In a bid to raise funds for future research and development, Samsung Bioepis is preparing to list on the US Nasdaq stock market as well, having hired four banks -- Citigroup, Goldman Sachs, Credit Suisse and Morgan Stanley -- to manage its initial public offering planned for 2016.

Though the size of the listing will depend on stock market conditions, the company is expected to be valued at 8 trillion won to 10 trillion won ($6.87 billion to $8.59 billion) and list 10 to 20 per cent of its shares, according to industry watchers, meaning an IPO could raise up to 2 trillion won.

Meanwhile, local biopharma developers including Samsung Bioepis, Celltrion, LG Life Sciences and Chong Kun Dang Pharmaceutical are expected to roll out more biosimilars in Korea by next year as many have already entered the final stage of clinical trials, according to the Ministry of Food and Drug Safety.

Though there are just five biosimilar drugs which have been approved in Korea -- four of which were introduced by homegrown pharma firms Samsung Bioepis, Celltrion and Hanwha Chemical -- 22 more biosimilar drugs are being newly developed.

A total of 16 biosimilars have entered Phase III of clinical trials, including three under development by Samsung Bioepis, one by LG Life Sciences, one by Celltrion and one by Chong Kun Dang Pharmaceutical, according to the ministry.

"Given that 16 out of 22 biosimilars have entered the final phase of clinical trials, more biosimilar drugs are forecast to receive approval starting from 2016," said a ministry official.

"The introduction of biosimilars is set to drive down the cost burden of Korean patients, given they are roughly 30 per cent cheaper than original brand-name biologic drugs."