FiercePharmaAsia—Samsung's Humira biosim; Celltrion's China JV; GenScript's new facility

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Samsung Bioepis, Celltrion and GenScript made our news this week. (Google)

As its biosimilars grow in Europe, Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics, has nabbed FDA approval for a Humira biosimilar. Celltrion is forming a joint venture with Hong Kong's Nan Fung Group to develop and commercialize three Celltrion biosims in China. China's GenScript, aiming to become a major player in gene and cell contract manufacturing, officially launched a clinical supply biologics plant. And more.

1. Samsung Bioepis wins FDA nod for Hadlima, a Humira biosimilar to be sold by Merck

Biogen keeps its foot on the pedal in biosims as Humira copycat takes 'market-leading' position

The FDA has approved Samsung Bioepis’ biosimilar to AbbVie’s blockbuster Humira. The drug, Hadlima, will be sold by Merck & Co. in the U.S. In the second quarter, biosimilar sales in Europe grew 45% to $184 million year over year, according to Biogen, which co-owns Samsung Bioepis with Samsung BioLogics. Biogen CEO Michel Vounatsos said the company’s Imraldi is a “market-leading” biosim to Humira. It also sells copycats to Merck’s Remicade and Amgen’s Enbrel in the EU.

2. Celltrion forms JV to develop 3 biosimilars in China

It was only in February that China approved its first biosimilar. Now, Korea-based Celltrion has paired with Hong Kong investment firm Nan Fung Group to form a biosimilar joint venture. The new company, Vcell Healthcare, will develop three Celltrion biosimilars that reference Remicade, Rituxan and Herceptin for the Chinese market.

3. Chinese CDMO GenScript takes steps to be player in China's gene and cell therapy market

Chinese CDMO GenScript, the parent company of Johnson & Johnson’s CAR-T partner Legend Biotech, has premiered a 9,300-square-meter (100,104-square-foot) clinical supply biologics production and R&D facility in Nanjing, China. The company is also building a 150,000-square-meter commercial supply center nearby. GenScript says the commercial center will be the largest such facility in China covering cell therapy, gene therapy and antibody drugs. 

4. Korea to invest $2.9B in new drug development government project (Korea Biomedical Review)

Three Korean ministries unveiled a joint “National New Drug Development Research Project,” which aims to pour 3.5 trillion won ($2.9 billion) into drug R&D over 10 years, beginning in 2021. Through the project, the agencies expect to license out $10 billion worth of technologies and export $16 billion worth of drugs by 2030.

5. Parexel launches Health Advances Asia, expanding global footprint with Hong Kong base

Parexel has launched Health Advances Asia to “support development of global expansion strategies for Asia/Pacific and multinational companies from new Hong Kong presence,” the CRO said. The Hong Kong-based team will be led by Gary Cheng, who joins with more than 30 years of life sciences experience with such firms as Novartis, BD, Chiron and more.