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Samsung kicks off biosimilar drug business

Samsung Bioepis’ Brenzys begins commercial sales, Renflexis approved by Drug Ministry in South Korea

Samsung Group’s up-and-coming biosimilar drug business -- led by its biopharmaceutical R&D unit Samsung Bioepis -- has officially taken off with the introduction of its first self-developed biosimilar treatment in the South Korean market.

Samsung Bioepis on Thursday began domestic sales of Brenzys, the firm’s biosimilar copy of Amgen and Pfizer’s blockbuster rheumatoid arthritis drug Enbrel (Etanercept), according to MSD Korea in charge of the drug’s local marketing and sales.

A day later, the company announced that Renflexis — its biosimilar version of another rheumatoid arthritis treatment Remicade (Infliximab) — has been approved by Korea’s Ministry of Food and Drug Safety and will hit the local market in the near future.

Samsung Bioepis’ Brenzys (MSD Korea)
Samsung Bioepis’ Brenzys (MSD Korea)

The commercialization of Samsung's new biosimilar drugs marks an important milestone in the conglomerate's latest push to expand into the field of biopharmaceuticals, more specifically biosimilars -- a promising industry set to become one of the conglomerate’s new cash cows.

Biosimilars are lower-cost replications of brand-name biologic drugs that have lost patent protection. Composed of living cells and naturally occurring proteins, biologics are more effective and more difficult to reproduce than conventional chemical-based drugs.

Founded in 2012 as a joint venture between Samsung and global biopharma company Biogen, Samsung Bioepis has been leading the conglomerate’s drive to rise up a sizeable force in the fast-growing biosimilar segment, forecast to form a multibillion-dollar industry in the years to come.

Brenzys is the first visible outcome of such efforts. The drug is priced at roughly 33 percent below the price of original Enbrel, available at 141,976 won ($123) for one 50mg dosage injection, according to MSD Korea.

“We are very happy to be introducing the very first output of a collaborative partnership between Samsung Bioepis and MSD foremost in Korea,” said Oh So-yun, business unit director of diversified brands at MSD Korea.

Brenzys, which has been proven in multiple clinical tests to be as effective and safe as the original drug, will “rise up as a new treatment option for patients, lowering the payment burden they face,” Oh said.

Samsung Bioepis CEO and president Ko Han-sung (Samsung Bioepis)
Samsung Bioepis CEO and president Ko Han-sung (Samsung Bioepis)

The biosimilar drug is awaiting entry into the European pharmaceutical market as well. Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on Benepali, another name for Brenzys.

Upon the European Commission’s marketing and sales authorization, which by protocol takes around 2 months, Benepali will become the first etanercept biosimilar to be approved and sold in the European Union.

Samsung Bioepis is currently working on developing five other biosimilar copies of major biologic drugs -- Remicade, Humira, Herceptin, Avastin and Lantus -- in line with their approaching patent expiration dates in the U.S. and Europe.

Renflexis, Samsung's Remicade biosimilar is expected to enter European markets in the near future after it receives final approval from the EMA.

The company recently successfully completed the Phase III clinical trials of its Humira biosimilar SB5 (Adalimumab), while its Herceptin biosimilar SB3 (Trastuzumab) and Lantus biosimilar SB9 (Insulin Glargine) are currently in the third-phase clinical trial stage.

Reflecting Samsung Group’s dedication to the biopharma business, Samsung Bioepis CEO Ko Han-sung was promoted to president from vice president in the group’s latest executive reshuffle announced earlier this week.

Meanwhile, Samsung Bioepis is preparing to list on the U.S. Nasdaq stock market by 2016, in a bid to attract new funding for future research and development activities. Industry watchers expect the initial public offering price to be about 8 to 10 trillion won ($6.87 billion to $8.59 billion).

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