Rentschler Biopharma Will Be Involved In Almost 25% Of The New Biopharmaceuticals Approved By The FDA In 2023

• 50 years of experience in biotechnology culminate in exceptional performance in therapy development from early stages of development to market readiness

55 new drugs were newly approved by the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) in 2023, including 17 biopharmaceutical drugs. Rentschler Biopharma SE, a leading services and contract development company (CDMO) for biopharmaceuticals including advanced therapy medicinal products (ATMPs), held an interest in four of these biopharmaceuticals - almost 25%.

Federico Pollano, Senior Vice President Business Development at Rentschler Biopharma, commented: “Successfully developing a promising new therapy - from the first clinical trials to market readiness - is a demanding undertaking that requires many years of careful development work. We offer our customers first-class solutions along the entire biopharmaceutical value chain, from bioprocess development to the manufacturing of their products to regulatory issues. The latest FDA approvals are excellent evidence of our ability to successfully guide our customers and partners through this challenging process. At the same time, they reflect the breadth of our offering and our flexibility, with which we meet the very different needs of our customers.”

Rentschler Biopharma currently produces a total of eight market-approved biopharmaceuticals for its customers, including complex formats such as bispecific antibodies and recombinant enzymes. For the four newly approved products, the company supported international customers with consulting services, regulatory issues, process development, technology transfer and production. Rentschler Biopharma's involvement in the successful development of these therapeutics to market demonstrates the company's strategic role in developing innovative therapies for patients suffering from cancer, autoimmune diseases and rare diseases. International customers were involved in these projects, underscoring the company's global reach and strong performance at its production sites.

Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “Together with our customers, we at Rentschler Biopharma create lasting benefits for people worldwide with serious and rare diseases. Medicines with market approval greatly help patients, their carers and doctors by giving them new treatment options. I am very grateful and proud that our company continues to make important contributions to the development and production of innovative biopharmaceuticals and brings our customers' ideas to maturity. My heartfelt thanks go to our cross-site teams for their significant contributions to this important milestone and for their commitment, which is reflected in every aspect of our work.”