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Exclusive interview: Samsung Bioepis' Sang-Jin Pak on the rise of biosimilars

Published on 02/12/19 at 12:22pm

Following on from our focus on biosimilars in our feature last week, you can read Nikhil Patel's interview with Sang-Jin Pak, Senior Vice President & Head of Commercial at Samsung Bioepis, where he discusses the increasing prevalence of biosimilar medications and where the company stands within this.

How do you think policymakers can make biosimilars more viable options in the US market to achieve greater uptake?

Biogen scoops up eye and anti-TNF drug rights from Samsung Bioepis in $300m deal

Biogen has struck a new deal with Samsung Bioepis, it has emerged, picking up the commercialisation rights to a raft of drugs including two new ophthalmology biosimilars and a range of anti-TNF therapies.

Specifically, the partnership gives Biogen the exclusive rights to market both SB11, a biosimilar of Lucentis, and SB15, a biosimilar of Eylea, in the US, Canada, Europe, Japan and Australia, in a bid to expand its offering in the eye therapy space. These two drugs brought in sales of $11 billion in 2018, with $5.8 billion of that made in the US alone.

Humira biosimilar from Samsung Bioepis and MSD wins marketing authorisation in the US

It’s another victory for MSD as the US drugmaker announced that its biosimilar version of AbbVie’s Humira – the world’s best-selling medicine – has received marketing authorisation from the FDA.

The approval for the drug, known as Hadlima and developed by Samsung Bioepis, covers the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, just like its reference product.

FDA approves third Herceptin biosimilar with Samsung Bioepis' Ontruzant

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), in the same indications as its reference product.

This includes three cancer indications: as an adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

MSD and Samsung Bioepis terminate development of Lantus biosimilar for diabetes

MSD has reportedly terminated a previous agreement with Samsung Bioepis which would have seen them collaborate on a biosimilar version of Sanofi’s Lantus (insulin glargine) for diabetes.

The deal, which was reached in February 2014 as an expansion of an existing agreement, concerned the development, manufacture and commercialisation of MK-1293, or Lusduna Nexvue.

MSD signs $117m deal with Samsung Bioepis over Janssen biosimilar

American multinational MSD have won a $117 million contract allowing them to supply Samsung Bioepis’ Renflexis to the US Department of Veteran Affairs.

The deal between the multibillion dollar pharma firm MSD, and the Samsung Biologics and Biogen Idec joint-venture Samsung Bioepis, will see MSD supply Renflexis, a biosimilar of Janssen’s Remicade (Infliximab) to the US federal agency that provides healthcare services to military veterans.

Samsung BioLogics’ shares down $6bn after accounting furore

Samsung BioLogics’ shares have been hit hard, after the South Korean company was handed a notice of suspected breach of accounting rules by the country’s financial regulator.

The notice was enough to send shares in the company spiralling down by 17.2% for the third largest contract manufacturer in the business, wiping $6 billion from the value of the company.

Samsung Bioepis and Biogen secure licensing deal with Abbvie for Humira biosimilar

Partners Biogen and Samsung Bioepis have secured the future of their Humira (adalimumab) biosimilar after penning a deal with Abbvie which grants patent licenses for the sale of the product in Europe and the US, and stipulates that the three parties agree to dismiss any ongoing litigation surrounding the issue.

Ontruzant launches to become first Herceptin biosimilar available in the UK

Ontruzant, the biosimilar version of Herceptin (trastuzumab ) originally developed by Korean firm Samsung Bioepis, has launched for patients in the UK, becoming the first biologic copycat version of Roche’s blockbuster to be available in the region.

MSD, better known as Merck across the Atlantic, is handling marketing as part of a global biosimilars development and commercialisation agreement with Samsung Bioepis.

Samsung Bioepis' Ontruzant becomes first Herceptin biosimilar approved in Europe

Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe by the EMA for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

The authorisation covers all 28 EU member states in addition to Norway, Liechenstein and Iceland and marks the fourth biosimilar from the company to be approved in the region. Samsung Bioepis has already secured approval for biosimilar versions of Humira, Remicade and Enbrel.

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