Biocon Biologics gets US FDA nod for Jobevne, expands oncology portfolio

Biocon Biologics Limited (BBL) announced on Thursday that it had received approval from the United States Food and Drug Administration (USFDA) for Jobevne, a biosimilar used to treat several types of cancer.

 

“The USFDA approval of Jobevne is a significant milestone, our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients,” said Shreehas Tambe, chief executive officer and managing director, BBL.

 

 

Jobevne works by blocking a protein called VEGF, which helps tumours grow new blood vessels. By stopping this process, known as angiogenesis, Jobevne helps cut off the tumour's blood supply, slowing or stopping its growth.

 

With US approval, Jobevne joins Biocon Biologics’ growing cancer drug portfolio in the country, which already includes biosimilars such as Ogivri (for breast cancer) and Fulphila (used to reduce infection risk during chemotherapy). The company also sells its version of Bevacizumab under the name Abevmy in Europe and Canada, where it was approved in 2021.

 

In the US, sales of Bevacizumab were approximately $2 billion in 2023, according to the company.

 

As of now, Biocon Biologics has commercialised nine biosimilars from its pipeline of 20 products in key emerging and advanced markets including the US, Europe, Australia, Canada, and Japan. Its pipeline includes several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.