Rentschler Biopharma involved in a quarter of the new biopharmaceuticals approved by the FDA in 2023

Therapy development from early development stages to market maturity

Rentschler Biopharma currently produces eight biopharmaceuticals for pharmaceutical clients

In 2023, 55 new drugs were approved by the Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). These included 17 biopharmaceutical drugs. Rentschler Biopharma was involved in the development of four of these biopharmaceuticals, i.e. almost 25 percent of the approvals in this area. Federico Pollano, Senior Vice President Business Development at Rentschler Biopharma, comments: “Guiding a promising therapy from its initial clinical trials to commercialization is a demanding endeavor that spans numerous years of development efforts. We provide clients with world-class solutions along the entire biopharmaceutical value chain from bioprocess development to manufacturing and regulatory support." 

Pollano adds: "These recent approvals illustrate our capability to support our client partners through this entire and challenging process, emphasizing the importance of our expertise and flexibility to match unique client needs.” Benedikt von Braunmühl, CEO of Rentschler Biopharma, emphasises: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide. Market approved products truly serve those patients and their caregivers by bringing them new therapeutic options. I am very grateful and proud that our company continuously makes important contributions in the development and manufacturing of innovative biopharmaceuticals and in realizing our clients’ ideas. My sincere gratitude goes to our cross-site teams for their integral contributions to this significant milestone and for their dedication, which is reflected in every aspect of our work.”

Contract manufacturing of eight authorised biopharmaceuticals

Rentschler Biopharma currently manufactures a total of eight authorised biopharmaceuticals, including complex formats such as bispecific antibodies and recombinant enzymes, on behalf of clients. For the four newly authorised drugs, the company supported its international clients with consulting services, regulatory issues, process development, technology transfer and production. Rentschler Biopharma's involvement in the successful development of these therapeutics to market maturity demonstrates the company's strategic role in the development of novel therapies for patients with cancer, autoimmune diseases and rare diseases. International pharmaceutical companies were involved in these projects, which underlines the global reach of the pharmaceutical service provider and the high performance of its production sites.

Rentschler Biopharma at the DCAT in New York

CEO Benedikt von Braunmühl and Senior Vice President Business Development Federico Pollano will attend DCAT Week in New York from 18 to 21 March to explain how Rentschler Biopharma supports its clients from concept to market.