UPDATE : Friday, June 5, 2020
Samsung Bioepis, Biogen to commercialize next-generation biosimilar candidates
  • By Lee Han-soo
  • Published 2019.11.07 11:16
  • Updated 2019.11.07 11:16
  • comments 0

Samsung Bioepis said the company would strengthen its partnership with Biogen, by signing a new contract for its new biosimilar candidates under development and extending the existing agreement between the two.

Samsung Bioepis headquarters in Songdo, Incheon.

The two companies plan to commercialize two biosimilar candidates new being developed by Samsung Bioepis -- SB11 (Ingredient: ranibizumab) and SB15 (Ingredient: aflibercept) -- in the United States, Canada, Europe, Japan and Australia.

SB11 is a biosimilar candidate referencing Novartis’ Lucentis and is undergoing phase 3 clinical trial. SB15, a biosimilar candidate referencing Bayer’s Eylea, is in pre-clinical development. Both drugs are macular degeneration treatments.

The agreement also provides Biogen with an option to extend the commercialization term for Samsung Bioepis’ three anti-tumor necrosis factor (TNF) biosimilars – Benepali, Flixabi, and Imraldi – in Europe for five more years, extending the original 10-year agreement.

According to the company, Benepali is the most prescribed etanercept-based drug in France, Germany, Italy, Spain and the United Kingdom, while Imraldi is the leading adalimumab biosimilar in Europe.

Under the accord, Biogen will also have an option to receive commercialization rights for the three anti-TNF biosimilars 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,” the company said.

Samsung Bioepis will receive upfront payments of $100 million and up to $270 million in milestone or option payments as well as sharing of sales revenue.

The Korean company will be responsible for developing, registering and making the products, while its U.S. partner will be responsible for commercializing them.

“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 European patients,” Samsung Bioepis President and CEO Ko Han-sung said. “By building on this collaboration, we are excited to expand the opportunity for people living with ophthalmological conditions, but without access to life-changing medicines.”

Samsung Bioepis will continue to demonstrate its enduring commitment to biosimilars by further strengthening its pipeline and widening its availability for patients and healthcare systems across the world, Ko added.


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