Biosimilar Developers Expand R&D Capabilities With New Facilities

This month, 2 biosimilar developers announced expansions of their research and development (R&D) capacities with the acquisition of new sites.

First, Fresenius Kabi announced the expansion of its biosimilar research activities in a new center in Eysins, Switzerland. The R&D center, in which the drug maker says it has invested approximately €15 million (US $16.5 million), will allow the company to intensify its biosimilar research in its focus areas of immunology and oncology.

Fresenius’ biosimilars unit currently has more than 100 employees, and the company says that it plans to expand this team by adding experts from different areas of specialization within biosimilars and biosimilars development in the future.

“Today is a big day for Fresenius Kabi and our Biosimilars business,” said chief executive officer (CEO) Mats Henriksson in a statement. “We are committed to finding the best answers for patients and healthcare professionals. Biosimilars are an outstanding way to help us fulfill our responsibility to provide high-quality products for the treatment and care of critically and chronically ill people. It is a fast-growing segment, and with these additional capacities in research and development, Fresenius Kabi will further strengthen its biosimilars pipeline.”

In addition to its EU-approved biosimilar adalimumab, Idacio, Fresenius Kabi’s biosimilar pipeline includes a tocilizumab biosimilar and a pegfilgrastim biosimilar, both in late-phase development, multiple undisclosed candidates that are in early development.

Separately, Biocon announced that its subsidiary, Biocon Biologics, has acquired R&D capital assets for a 60,000-square foot biologics research facility in Chennai, India.

The facility will accommodate 250 scientists, and will house an early-stage research and innovation center that will included a pilot-scale R&D unit, cell line development, drug substance process development, formulation laboratories, and analytical laboratories.

Biocon says that it plans for the facility to be operational in the coming months after qualification.

Christiane Hamacher, PhD, CEO of Biocon Biologics, said in a statement that “The high-end integrated R&D facility in Chennai will enable Biocon Biologics to expand its R&D capability and accelerate its journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. This investment will allow us to fast-forward development of our biosimilars from lab to pilot scale. R&D is at the core of what we do and I believe this facility will enable us to pursue breakthrough innovation in pursuit of providing affordable access to high quality biosimilars and inclusive healthcare solutions aimed at transforming patient lives globally.”

Currently, Biocon boasts US- and EU-approved biosimilars of trastuzumab and pegfilgrastim, as well as an EU-approved insulin glargine biosimilar. The drug maker is developing various biosimilar assets together with Sandoz, as well as products including pertuzumab, filgrastim, bevacizumab, insulins, and others with Mylan and local partners.