Stalling biosimilars give Roche confidence to reopen Genentech plant

When Roche ($RHHBY) bought Genentech in 2009, it swelled its biologics production footprint, but it was unsure whether biosimilar completion would leave it with excess capacity. The doubt prompted Roche to shutter a Genentech cell culture facility before it ever produced a drug, a decision it is now overturning.

Genentech began work on the cell culture facility--the second at its Vacaville, CA, site--in 2007, but Roche closed the plant shortly after buying the biotech, laying off 100 staffers in the process. Roche feared competition from biosimilars would lessen demand for blockbuster biologics, notably Rituxan, produced at the plant. However, with rivals' efforts to develop a biosimilar Rituxan stalling, Roche last month said it is reopening the facility and hiring 200 workers to produce the cancer blockbuster and other drugs.

This week, Genentech revealed more details of the project, which it says will benefit from the foresight of those involved in the shuttering of the facility. "Despite the closure of this plant for the past three years, most of the existing equipment is still in very good condition and was preserved so that it would not deteriorate over time," Jon Reed, VP and general manager for manufacturing operations at Genentech, told the North Bay Business Journal.

The retention of the original equipment means Genentech will only need to replace some older instruments, add automated devices and make minor construction changes. Reed expects to have finished these refurbishments and be ready to produce test batches by June, after which Genentech will take a year to get the plant fit for commercial manufacturing. By then, biosimilar versions of Rituxan may have arrived, but Roche is confident its portfolio will generate enough demand for the reopened plant's 200,000-liter cell-fermentation capacity.

Roche won FDA approval for its Rituxan successor, Gazyva, this week and expects demand for the new product and others in its pipeline to necessitate an expanded biologics manufacturing network. Over the past month, Roche has detailed plans to invest in capacity in Vacaville and Oceanside in California, Penzberg in Germany and Basel in Switzerland. As well as boosting in-house capacity, Roche is outsourcing some biologics production to the massive Korean conglomerate Samsung.

- read the North Bay Business Journal article
- here's FierceBiotech's Gazyva piece