Pipeline Updates: Pfizer, Amgen, and Allergan

Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development.  According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key therapeutic areas of research.”

Last week, Amgen and Allergan announced positive results from a Phase 1/Phase 3 study evaluating the pharmacokinetics, efficacy and safety of ABP 798, Amgen and Allergan’s biosimilar candidate to RITUXAN® (rituximab), compared to rituximab, in patients with moderate-to-severe rheumatoid arthritis.  According to David M. Reese, M.D., executive vice president of Research and Development at Amgen, “[r]esults from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab.”

Yesterday, Amgen announced that in December of last year, it submitted a BLA for a biosimilar of Remicade® (infliximab) and  resubmitted a BLA for KanjintiTM, a biosimilar of Herceptin® (trastuzumab).  Additionally, Amgen announced that this month, it submitted a Marketing Authorization Application to the EMA for its Remicade® biosimilar.