Tuesday, March 12, 2019 Daily Archives

Pfizer’s trastuzumab becomes US biosimilar number 18

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The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab). Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past…

March 12, 2019

CDMO Fujifilm buys Danish plant from Biogen for $890m

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Biogen has sold a 90,000 L mammalian cell culture to Fujifilm Diosynth Biotechnologies. The deal propels the CDMO into the top 10 of biomanufacturers based on tank capacity. The manufacturing plant in Hillerød, Denmark will be taken over by contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, with all the approximately 800 staff members being retained, in the $890 million (€790 million). “The plan is for Fujifilm to use the Hillerød site to produce commercial products for Biogen as well…

March 12, 2019

High-Viscosity Mixing: Choosing the Right System for the Job

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Manufacturers of topical ointments, gels and lotions for BioPharma, personal care and other high-viscosity products face critical product quality challenges in their mixing processes. The better these challenges are understood, the more specific the design and configuration of processing equipment can be, to optimize product quality and maximize plant productivity. Unfortunately, conventional mixing systems may limit the ability of product manufacturers to optimize productivity and efficiency. The inefficiency of conventional dual-agitated vessels, multiple mixing vessels, and the operational complexity of…

March 12, 2019

Cellectis builds out CAR-T network, creates 200 jobs in NC

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Cellectis will build a clinical and commercial production plant in Raleigh at a reported cost of $68 million and a raw material facility in France to support its allogeneic CAR-T pipeline. France-headquartered Cellectis is looking to develop off-the-shelf chimeric antigen receptor (CAR) T-cell therapies using its TALEN gene-editing technology. Cellectis manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs) but is now looking to securing inhouse supply through investments in Raleigh, North Carolina, and…

March 12, 2019

Biosimilar… but different: FDA tweaking nonproprietary name guidance

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The US FDA has proposed changes to its nonproprietary naming guidance to remove the proposed controversial four-letter suffix from older biologics. In 2017, the US Food and Drug Administration (FDA) published guidance to include a random four-letter suffix to the international nonproprietary names (INN) of all biological products. The ruling essentially distinguished a biosimilar from its reference product, so Amgen’s reference product Neupogen, for example, is known as ‘filgrastim-jcwp,’ while Sandoz’s biosimilar version Zarxio – the first biosimilar approved and…

March 12, 2019