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Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US  As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm  Quallent will provide high-concentration (40mg/0.4mL)…

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Boehringer Ingelheim

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023  The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…

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Insights+ Key Biosimilars Events of October 2023

Insights+ Key Biosimilars Events of October 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…

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VIEWPOINTS_Stephen Pagnotta_2023

Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo

Shots: Stephen gave a brief introduction about Cyltezo (an FDA-approved interchangeable Humira biosimilar) and spoke about the features of the Cyltezo Pen (a new autoinjector) approved by the US FDA He also gave a comparative view of the Cyltezo Pen vs. the conventional Cyltezo PFS. He also talked about how BI is informing and educating…

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