Bionpharma and STEERLife, the life sciences division of STEER World, have announced U.S. FDA approval of a generic tablet for treatment of HIV/AIDS.

Etravirine, developed using STEERLife’s proprietary continuous manufacturing platform known as FragMelt, received Abbreviated New Drug Application status. Bionpharma will now lead commercialization and distribution of etravirine in the United States.

Bionpharma, STEERLife Leaders React

“This ANDA approval is a testament to the power of aligning scientific insight with advanced engineering from day one,” said Venkat Krishnan, Bionpharma CEO. “Our collaboration with STEERLife has converted a technically challenging product into a scalable, high-quality product ready for the competitive U.S. market.”

“FragMelt and our continuous processing approach were engineered specifically to solve complex formulation challenges such as these,” said Indu Bhushan, CEO and Director of STEERLife. “This approval not only validates our platform but also reinforces the immense value of collaborative development and technology transfer in the generic pharmaceutical space.”

Affordable HIV/AIDS Treatment

Bionpharma and STEERLife said the FragMelt platform enables a sustainable and solvent-free route of manufacturing. In addition, it permits strict bioequivalence to the reference product, INTELENCE. That product first got marketing authorization in 2008, awarded to what is now Johnson & Johnson Innovative Medicine.

The companies involved in this latest FDA approval said etravirine is an important, second-line antiretroviral therapy in HIV/AIDS treatment. However, development of the generic tablet presented significant challenges due to extreme sensitivity to heat and shear.

Bionpharma and STEERLife said their product is stable, reproducible, and regulatory-compliant, and will be more affordable for Americans.

The collaboration between the companies, according to a press release, highlights the benefits of integrated development in accelerating time-to-market. The continuous manufacturing process is additionally intended to make drug development cleaner and greener.