Tuesday, September 4, 2018 Daily Archives

False biosimilar communications: Originators rebuff Pfizer’s claims

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.†The firm continued: “Dissemination of false or misleading…

KBI boosts analytical services with Belgium expansion

The laboratories in Belgium will help international biopharma firms consolidate their outsourced analytical work to meet EU regulations, says KBI Biopharma. Contract development and manufacturing organization (CDMO) KBI Biopharma has opened laboratories in Leven, Belgium offering analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing. According to CEO Tim Kelly, the lab expansion was first announced in 2015, when the CDMO was acquired by JSR Corporation. “JSR’s decision to expand its A3 production capacity in Leuven created an…