SEOUL – Samsung Bioepis Co. Ltd., an affiliate of Samsung Group, plans to supply its biosimilar Enbrel, SB4, from partner Biogen Inc.'s plant for the South Korean and European markets, and the aim is to mass produce the product as soon as it receives approvals, said a company official.

"It takes about 14 to 16 months to complete the regulatory process in Europe, so we expect to receive the approval in the first half of next year. Similarly, we expect to gain approval from MFDS [South Korea’s ministry of food and drug safety] late this year or early next year," said the official.

The company also expects to receive approvals in South Korea and Europe for SB2, its Remicade (infliximab) biosimilar candidate, around the same time as SB4, after submitting a marketing authorization application (MAA) to the European Medicines Agency on Mar.19.

For the rest of its biosimilar pipeline, it will start to apply for approvals from next year, the official disclosed.

In March, the company applied for the approval in South Korea of the production and sales of SB4. If approved by the MFDS, Samsung Bioepis will be the third South Korean pharma firm to produce a biosimilar (of any type) in the country after Celltrion Inc. and Hanwha Group ([A#28150315003]).

In January, Samsung had said the European MAA for the biosimilar candidate had been validated and accepted for review by the EMA, marking the first Enbrel biosimilar to advance into regulatory review in the European Union.

The firm said the MAA was based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis.

Noting that Enbrel in Europe is indicated for the treatment of a number of rheumatic diseases, including moderate to severe rheumatoid arthritis, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis, Samsung said SB4 could be available for use in all of the same indications as Enbrel.

Samsung Bioepis has conducted SB4 Phase I and Phase III clinical trials, and the MAA for the etanercept biosimilar was based on data from the Phase III multicenter study in Europe, where SB4 demonstrated its comparability to Enbrel.

In 2012, Enbrel had global sales of almost $8 billion. Amgen Inc. co-promotes the tumor necrosis factor inhibitor in the U.S. and Canada under a profit-sharing agreement with Pfizer Inc., while Pfizer has rights to sell Enbrel in other territories with Amgen receiving a royalty ([A#28130711006]).

Broader Plans

Samsung Bioepis is a joint venture with Biogen Idec, under which Samsung is aiming to take advantage of its partner’s expertise in protein engineering, biologics manufacturing and commercialization. Samsung Bioepis's sister company Samsung BioLogics plays the role of a contract manufacturing organization ([A#28120228002]).

Samsung Bioepis has been proceeding with development of biosimilars with Merck & Co. Inc. under a partnership reached in February 2013. The two companies have five biosimilars in Phase III development and plan to file them for approval in 2015 and 2016, Merck's Biosimilars Business general manager Dora Bibila said in a recent interview Also see "Merck’s Revised Biosimilar Strategy Poised To Deliver" - Pink Sheet, 6 April, 2015..

Besides Enbrel and Remicade, the other biosimilars currently in the pipeline include Roche's Herceptin (trastuzumab), AbbVie Inc.’s Humira (adalimumab) and Sanofi’s Lantus (insulin glargine), and are now under international Phase III trials in Asia, Europe and the U.S.

This is the biggest biosimilar pipeline at a South Korean firm.

Biomedicine is one of the sectors that the Samsung Group, South Korea’s biggest conglomerate, has been aiming to grow and become a leader in the global market. The group aims to invest KRW2.1 trillion ($1.92 billion) in the biopharma sector by 2020.

[Editor's note: This story was contributed by PharmAsia News, which provides in-depth coverage of Asia business and regulatory developments.]

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