Samsung Bioepis inks biosimilar deals to enter China

Samsung Bioepis has teamed with C-Bridge Capital to bring its third-wave biosimilars to the Chinese market.

C-Bridge will establish a new company, AffaMed Therapeutics, under terms of the deal, and will license multiple biosimilar candidates from Samsung Bioepis to commercialize in China. These include the third-wave biosimilar candidates SB11 and SB12 – versions of Roche/Novartis’ Lucentis (ranibizumab) and Alexion’s Soliris (eculizumab) – and SB3, a biosimilar of Roche’s Herceptin (trastuzumab).

The deal comes weeks after a partnership deal with 3SBio Inc to help bring other Samsung Bioepis biosimilar candidates into China, including a version of Roche’s Avastin (bevacizumab).

Samsung Bioepis has teamed with C-Bridge Capital and 3SBio in separate deals to commercialize biosimilars in China

“We are proud to have partnered with established leaders at the forefront of the Chinese biopharmaceutical industry,” Samsung Bioepis spokesperson Mingi Hyun told BioProcess Insider.

“With strong local partners in C-Bridge and 3SBio, we believe we are optimally positioned to help meet the need for high-quality biologic medicines across China.”

Changing Chinese regulations

Hyun added that Samsung Bioepis believes “the recent regulatory changes in China have given us more clarity and greater confidence in the Chinese market.”

In 2011, China’s National Medical Products Administration (NMPA) – then known as the SFDA – began an overhaul of how pharmaceuticals are manufactured, researched, clinically developed, regulatory reviewed and approved, moving more to global alignment and making it easier for multinational firms to enter the market.

“We remain committed to supporting ongoing efforts within China to improve the quality of healthcare for patients across the country. If approved, we believe our biosimilar candidates will have strong potential to play an important role in the Chinese healthcare system, as evidenced in what our biosimilars have begun to do in a growing number of countries across the world.”

The company – a joint venture between Samsung BioLogics and Biogen – has four biosimilars approved and marketed in the EU, and two approved in the US.

“As our industry-leading biosimilar pipeline continues to expand, we will continue to examine partnership opportunities in other territories,” said Hyun. “We aim to partner with companies whose expertise best match the capability requirements to drive the uptake of our biosimilars.”