Recently launched Cinfa Biotech just treated the first subjects in a clinical trial with its biosimilar of Neulasta®!
Cinfa Biotech just announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia. Though chemotherapy is highly effective against cancer, it is also an ordeal for the patient due to its harsh side effects. One example of these side effects is the depletion of neutrophils, leading to a decreased or nonexistent immune response. That is exactly where pegfilgrastim comes in. Cinfa Biotech’s biosimilar, called B12019, is a G-CSF receptor agonist used to stimulate bone marrow to produce more neutrophils and ultimately decrease the incidence of infections in patients undergoing chemotherapy.
Neulasta® is today widely used for different types of cancers and represents a market of about €3.5 bn. The high medical need and the upcoming expiration of Amgen’s patent are pushing forward the development of biosimilars that can offer a more affordable alternative for patients (N.B: biosimilars have an estimated average discount of 15 to 40% compared to the original molecule). Cinfa Biotech has everything to succeed in leading this race!
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. The company was founded in 2013 and received an initial investment of €70 million from its parent company, Infarco, to create a pipeline of biosimilar drugs to address the growing need for affordable therapies. A complete team of experts with decades of in-depth experience is developing biosimilars for a range of indications.
With 50 years’ experience, Cinfa Biotech’s parent company Infarco today employs over 1,200 people and reinvests an average of 90% of its annual profits into its portfolio companies, thereby driving their development and innovation. As Dr Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, explained to us: “Without innovation and permanent improvement, it is impossible to stay on top of the future of the pharmaceutical market. Infarco has understood this and is reinvesting a lot to enhance innovation in this field.”
B12019, the lead development program of Cinfa Biotech, has already completed preclinical studies, and its manufacturing process has been implemented at commercial scale. This new 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 enroll 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. Agreement with the EMA on the program also includes a second clinical study to address the immunogenicity of B12019.
2015 has definitely been a good year for the biosimilar market. Last month, the first biosimilar was approved in the US and the global biosimilar market is expected to reach €23 bn by 2020.
The recent launch of the first monoclonal antibody biosimilar represents the beginning of a new generation of biosimilars. At Cinfa Biotech, we believe that this new generation of products will make the market grow significantly in the coming years”
B12019 is the first product candidate within Cinfa Biotech’s clinical pipeline. The company is working on other candidates in a range of indications, including cancer and inflammatory diseases. Cinfa Biotech is on the starting block and is definitely ready to become one of the European leaders of the biosimilar race!