On July 20, the US Food and Drug Administration (FDA) approved the second biosimilar version of filgrastim. Pfizer's filgrastim biosimilar is named Nivestym™ (filgrastim-aafi). The originator product, Amgen’s Neupogen®, has steep competition from two other products (Sandoz’s Zarxio® [filgrastim-sndz] and Teva’s Granix® (tbo-filgrastim]). Granix was approved as a follow-on biologic, before the biosimilar pathway was … Continue reading Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
Tag: Teva
FDA Approval Eludes Amgen for Biosimilar Trastuzumab
Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab . On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin® biosimilar. In a brief press release, Amgen announced receiving the complete response letter for ABP 980. In the announcement, it also said that the … Continue reading FDA Approval Eludes Amgen for Biosimilar Trastuzumab
FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab. The content of the complete response letter was not revealed by Sandoz. This marks the second rituximab biosimilar rejected by the FDA. Celltrion and Teva’s Truxima™ was also rejected in early April. … Continue reading FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
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
Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
Celltrion and its partner Teva were dealt a significant blow today, as the Korean manufacturer announced that the latest two biosimilar candidates were rejected by the Food and Drug Administration (FDA). As first reported by Dan Stanton in the Biopharma Reporter, the FDA issued complete response letters as a result of inspection problems uncovered at … Continue reading Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
Teva’s Syprine Generic Priced 14% Below Jacked Up Valeant Product Price
In an announcement that surprised few, Teva Pharmaceuticals announced that its generic version of trientine hydrochloride (Syprine®) for the treatment of Wilson’s disease will be sold for a very nongeneric price. Also unsurprising, Teva executives did not address the fact that the price of Syprine had been jacked up astronomically by Valeant Pharmaceuticals only recently, … Continue reading Teva’s Syprine Generic Priced 14% Below Jacked Up Valeant Product Price
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
Two New Trastuzumab Biosimilars Submitted for FDA Approval
The team of Mylan and Biocon may have some company in the biosimilar competition for Herceptin® (trastuzumab). Two additional partnerships announced the filing of their 351(k) applications for trastuzumab biosimilars. Amgen and Allergan are hoping ABP 980 will have smooth sailing through the approval system. The phase 3 study in patients with early-stage HER2-positive breast … Continue reading Two New Trastuzumab Biosimilars Submitted for FDA Approval
Biosimilar Rituximab Under FDA Review
Celltrion announced June 30, 2017 that it has submitted its 351(k) application to the Food and Drug Administration for approval of its biosimilar version of rituximab. This represents the first biosimilar application for rituximab, a monoclonal antibody to CD20.
Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?
In Europe, several manufacturers are marketing approved biosimilars to the same originator product. In fact, 7 manufacturers compete for the biosimilar filgrastim market, 5 biosimilar versions of epoetin are sold, and 3 biosimilars of infliximab seek marketshare from Remicade®. In the US, this situation is not a reality yet. It will be one day, however, and … Continue reading Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?