An unusual market situation awaits Pfizer’s new biosimilar epoetin, one that few approved medications has to face. Not only does Retacrit® need to pass muster with payers like health plans and insurers, which we assume it will, but Retacrit will need to be accepted by the two 800-pound gorillas of the kidney dialysis field as … Continue reading Convincing Two Main Providers the Key to Pfizer’s Retacrit® Success
Tag: Pfizer
Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end. After an initial rejection, … Continue reading Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used to encourage use of the originator product. In fact, … Continue reading Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
When Pfizer announced that it received a complete response letter from the Food and Drug Administration (FDA), the wait for an available biosimilar to Herceptin® just got longer. According to the manufacturer, the FDA specified that the reasons for the rejection of PF-05280014 were not related to clinical questions. The rejection was not associated with … Continue reading Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
FDA’s Gottlieb to Health Plans: Move Away From Short-Term Rebates on Reference Drugs to Enhance Long-Term Biosimilar Savings
According to Food and Drug Commissioner Scott Gottlieb, MD, the managed care sector’s willingness to accept larger rebates from manufacturers of originator biologics to preserve formulary coverage may seriously hinder the long-term success of the biosimilar industry. And more importantly, the ability to control biologic costs through competition. In remarks made to a national meeting … Continue reading FDA’s Gottlieb to Health Plans: Move Away From Short-Term Rebates on Reference Drugs to Enhance Long-Term Biosimilar Savings
Pfizer US Biosimilar Revenues Growing Slowly, Better News Internationally
According to an article posted on the Market Realist website, Pfizer’s US and global biosimilars revenues are growing, but its sales of Inflectra® remain stunted. In the fourth-quarter of 2017, the New York–based company posted US biosimilar revenues of $44 million—all attributable to its infliximab biosimilar. The product was launched in Q4 2016 (and gained … Continue reading Pfizer US Biosimilar Revenues Growing Slowly, Better News Internationally
Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
The US Court of Appeals handed Pfizer a big victory in its gamble to bring its biosimilar version of Remicade® to the market before the completion of patent litigation. On January 23, the Appeals Court ruled that Johnson & Johnson’s ‘471 patent in the case was declared invalid, clearing the way for sales of Inflectra® … Continue reading Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
On December 14, Pfizer got an early Christmas present, the approval by the Food and Drug Administration (FDA) of the second infliximab biosimilar in which it has a stake. First came Inflectra® in 2016, and here comes Ixifi™ (infliximab-qbtx). Unlike Inflectra, which Pfizer markets for Celltrion, Ixifi is Pfizer’s alone—a product that was under development … Continue reading A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
A Health System Biosimilar Survey’s Implications
When asked about potential cost savings with the infliximab biosimilar, nearly one-quarter of health system respondents did not believe that it represented a cost savings opportunity for their organization, according to a newly published survey in the Journal of Managed Care and Specialty Pharmacy. Conducted by Premier, Inc., a group purchasing organization, 57 US health … Continue reading A Health System Biosimilar Survey’s Implications
Fuzzy Patent Logic
Three other biosimilar manufacturers have already filed for approval in the US: Amgen/Allergan and Celltrion/Teva (separately) in July 2017; Mylan/Biocon in November 2016. Roche settled its patent claims against Mylan in March 2017, which provides Mylan with a license to sell its biosimilar version of Herceptin® should it gain FDA approval next year.