When payers, patients, or physicians discuss biosimilars, they assume that the biosimilar works just like the reference product. They also assume that the biosimilar is administered in the same way as the originator biologic. Celltrion is actively researching a new subcutaneous infliximab. This could result in a first for the biosimilar industry. Sponsored by Celltrion … Continue reading Is Celltrion Paving a New Road for Biosimilars? A New Route of Administration Being Tested for Infliximab
Tag: Celltrion
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
Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
Anticipating that its issues with the Incheon, South Korea, manufacturing plant will be resolved, Celltrion has resubmitted its biologic license application for a rituximab biosimilar (CT-P10). In the April 2018 complete response letters sent by the Food and Drug Administration (FDA) on CT-P10 and the trastuzumab biosimilar CT-P6, FDA cited aseptic practices at the manufacturing … Continue reading Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
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
With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023. This is the second deal Abbvie has made with a potential competitor, confirming the solidity of its patent wall. The European patent expires in October 2018, and competitors … Continue reading With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
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
Celltrion and Inflectra, Mylan and Botox, and a Biosimilar Blooper
The second quarter is expected to be rife with news regarding Food and Drug Administration approval decisions on a biosimilar for rituximab and two pending applications for trastuzumab. Although biosimilars have not generated much news of importance lately, we wrap up the week with some items of interest. First, Celltrion estimates that it will conclude … Continue reading Celltrion and Inflectra, Mylan and Botox, and a Biosimilar Blooper
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)