FDA approves 18th biosimilar; Fujifilm grabs Biogen’s biologics plant in Denmark

By PharmaCompass

2019-03-14

Impressions: 113 Article

Biotech and pharma companies are increasingly expanding into Europe, and joining the bandwagon is Fujifilm, a Japanese company that specializes in pharmaceutical manufacturing, bio CDMO (contract development and manufacturing organization) and as well as regenerative medicine.

This week, Biogen announced Fujifilm has agreed to buy its biologics manufacturing facility at Hillerød (Denmark) for US$ 890 million in cash. In addition, Fujifilm has also agreed to supply Biogen with some products manufactured there, including multiple sclerosis drug Tysabri.

Meanwhile, Biogen is opening brand-new biologics facility in Switzerland along with manufacturing facilities at Research Triangle Park, North Carolina, a company statement said. Two months back, Fujifilm had announced its plans to invest US$ 90 million (10 billion yen) to expand its Bio CDMO facilities in North Carolina.

The surge in companies increasing their biologics manufacturing capabilities can, in part, be attributed to the speed at which the FDA has been approving biosimilar products — the latest of them being Pfizer’s Trazimera. Trazimera (trastuzumab-qyyp) is the fourth biosimilar of Roche’s Herceptin (trastuzumab) and FDA’s 18^th biosimilar approval.

However, it is intriguing that none of the other three approved Herceptin biosimilars have yet been launched in the US. The last trastuzumab biosimilar to be approved is Ontruzant, developed by Samsung Bioepis, which received approval in January this year.

Roche even filed a lawsuit against Pfizer, seeking to prevent the launch of a biosimilar trastuzumab in the US marketplace in November 2017. The approval of Pfizer’s Trazimera comes months after the biopharma majors reached a mutual settlement at a federal court in Wilmington, Delaware.

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