Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapyinduced neutropenia. B12019 is a pegylated granulocyte colony-stimulating factor (GCSF) receptor agonist, which is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing
B12019, the lead development program of Cinfa Biotech, has completed preclinical studies, and the manufacturing process (GMP) for B12019 has been implemented at commercial scale. This trial is the first part of a clinical development program investigating the clinical comparability of B12019, which has been designed based on the longstanding expertise of Cinfa Biotech’s team in developing biosimilars.
The single dose, cross-over study will enrol up to 170 healthy volunteers in Germany. It primarily investigates the pharmacokinetics (PK) and the pharmacodynamics (PD) of B12019 as compared to Neulasta®. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.
Dr Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, said: “I’m proud of the team for having designed such an efficient, tailored development program in line with the biosimilars concept to develop affordable therapies based on proven quality, safety and efficacy. Agreement with the EMA on the program, which includes a second clinical study to address the immunogenicity of B12019, underlines that our development program has been designed based on solid science and the latest regulatory considerations. It corroborates our expectations to achieve a timely submission for approval in Europe. This is the first product candidate within a pipeline of high quality biosimilars for a range of indications, including cancer and inflammatory diseases.”
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. The company was founded in 2013 and received an initial investment
of EUR 70 million from its parent company Infarco to create a pipeline of biosimilar drugs to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is developing biosimilars for a range of indications. The commercialisation models will be customised to the needs of partners and markets. Product development, clinical studies, manufacturing and
quality control at Cinfa Biotech are conducted in Europe according to the highest European standards.
Infarco, the parent company of Cinfa Biotech, holds a portfolio of pharmaceutical companies. With 50 years’ experience, Infarco represents the successful professional approach of a group of pharmacists to recover the central role of pharmacists in the pharmaceutical industry. The Company today employs over 1,200 people and reinvests an average of 90% of its annual profits in its portfolio companies, thereby driving their development and innovation.
Infarco’s first subsidiary, Laboratorios Cinfa, has become a successful developer and manufacturer and a recognised leader in the Spanish pharmaceutical market; it is the laboratory with the strongest presence in Spanish homes. As part of the internationalization strategy, the company serves markets in currently over 50 countries and is further expanding.
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