Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates

Samsung Bioepis Co., Ltd. announced today that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing LUCENTIS^®ii (ranibizumab), is undergoing phase 3 clinical trial, while SB15, a biosimilar candidate referencing EYLEA^®iii (aflibercept), is in pre-clinical development.

In addition, the agreement provides Biogen an option to extend the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars – BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab) – in Europe for additional five years, extending the original ten-year agreement.¹ BENEPALI™ is the most prescribed etanercept in France, Germany, Italy, Spain, and the United Kingdom (UK).^iv IMRALDI™ is the leading adalimumab biosimilar in Europe.^iv

The agreement also provides Biogen an option to receive commercialization rights to BENEPALI™, FLIXABI™ and IMRALDI™ in China in exchange for royalties on sales in the market.

The agreement is a testament to Samsung Bioepis’ strong track record in the field of biosimilars and the potential value that Samsung Bioepis’ ophthalmology biosimilars could deliver to patients and healthcare systems across the world. Under the agreement, Samsung Bioepis will receive upfront payments of USD 100 million, up to USD 270 million in milestone/option payments, as well as sharing of sales revenue. Samsung Bioepis will be responsible for development, regulatory registration, and manufacture of the products, while Biogen will be responsible for commercialization.

“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe. By building on this collaboration, we are excited to potentially expand the opportunity for patients living with ophthalmological conditions, who don’t have access to life-changing medicines,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”

Samsung Bioepis’ products are now available across Europe, North America, Asia, Oceania, and Latin America. The company currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT^® (trastuzumab). In the United States, the company has one biosimilar – RENFLEXIS^® (infliximab-abda) – approved and marketed. ONTRUZANT^® (trastuzumab-dttb) received approval from the U.S. Food and Drug Administration (FDA) in January 2019, while ETICOVO™ (etanercept-ykro) and HADLIMA™ (adalimumab-bwwd) received FDA approval in April and July 2019, respectively.

¹ The effective dates of commercialization differ for each anti-TNF product based on the launch dates. BENEPALI ™ and FLIXABI ™ were launched in Europe in January and May 2016, respectively, while IMRALDI ™ was launched in October 2018 in Europe.

About BENEPALI™ (etanercept)

BENEPALI™ (etanercept), a biosimilar referencing ENBREL^®v, was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis, pediatric plaque psoriasis. BENEPALI™ is currently available in 25 countries in Europe and is the most prescribed etanercept in France, Germany, Italy, Spain and the United Kingdom.^iv

About FLIXABI™ (infliximab)

FLIXABI™ (infliximab), a biosimilar referencing REMICADE^®vi, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI™ can also be used in patients 6-17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI™ is currently available in 17 countries in Europe.^iv

About IMRALDI™ (adalimumab)

IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA^®vii, was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis. IMRALDI™ is currently available in 19 countries in Europe and is the leading adalimumab biosimilar in Germany and in Europe year to date 2019. ^{iv, viii}

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

ⁱ Data on file: Biogen, Inc. Third Quarter 2019 Financial Results and Business Update, Oct 22, 2019
ⁱⁱ LUCENTIS^® is a registered trademark of Genentech
ⁱⁱⁱ EYLEA^® is a registered trademark of Regeneron Pharmaceuticals
^iv Data on File: IQVIA, GERS, Insight Health ODV
^v ENBREL^® is a registered trademark of Pfizer/Amgen
^vi REMICADE^® is a registered trademark of Janssen
^vii HUMIRA^® is a registered trademark of AbbVie
^viii Data on File: Biogen data on file

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Contact information

MEDIA CONTACT:
Na Yun KIM
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nayun86.kim@samsung.com