Cinfa Biotech presents additional data for pegfilgrastim biosimilar candidate B12019

November 8, 2017 9:53 AM

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Cinfa Biotech S.L., the biosimilars company of Cinfa Group, announced that it will present additional data from the clinical development program of its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia.

The new data will be presented during a poster presentation at the 59th American Society of Hematology (ASH) Annual Meeting 2017 in Atlanta, USA, from December 9-12, 2017.

The poster titled: “Comparability of Pharmacodynamics and Immunogenicity of B12019, a Proposed Pegfilgrastim Biosimilar to Neulasta will be presented on Saturday, December 9 and an abstract is now available at http://www.hematology.org/Annual-Meeting

Based on scientific advice from EMA, the clinical development program for B12019 included a pivotal and a supportive clinical study. Pharmacokinetic (PK) and pharmacodynamic (PD) comparability between Neulasta and B12019 in the pivotal study had been previously shown (Blood 2016 128:5079). The data to be presented at the ASH Annual Meeting 2017 are from the supportive study. They provided, together with the data from the pivotal study, the clinical basis for the marketing authorization application that was accepted for review by the EMA, as reported in October 2017.

The supportive study investigated the immunogenicity and PD comparability of B12019 and Neulasta at a reduced dose of 3 mg. This dose is considered to be more sensitive to detect potential differences in PD between B12019 and Neulasta as compared to the clinical dose of 6 mg. The study confirmed the comparability in PD and immunogenicity of B12019 with Neulasta at the reduced dose.

Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech, commented: “We are proud to present new data of our clinical development program at the ASH Annual Meeting. The recent MAA acceptance in Europe and the robust B12019 development data provide an excellent basis for finalizing the partnering activities in Europe and to initiate partnering activities in the US.

Source: Cinfa Biotech

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