The business is the largest contributor to the biopharmaceutical company’s topline, and the fastest growing, as over the last few years many of its drugs received commercial approval in the mature markets of US and Europe.
In an interaction with TOI, Mazumdar-Shaw said the biologics business was growing, but not at the level she wants it to. “We need a higher pace of growth,” she said. While the unit grew 11% in the third quarter compared to the same period last year, sequentially it grew lower than the 14% it grew in the second quarter. Total revenue at the end of nine months was Rs 2,137 crore.
Biocon said last year it plans to take the business public in 2-3 years to unlock value. It was betting on biologics clock total revenue of $1 billion by fiscal 2022. That, Mazumdar-Shaw said, was unlikely to happen now.
Biosimilars or biologics are drugs made from complex molecules manufactured using living microorganisms, plants, or animal cells. Though there are no differences in terms of safety and effectiveness from the main product, they are not considered duplicates, like generics, as it is impossible to manufacture exact copies of biotech drugs.
“The challenges are more than we anticipated. In the beginning, people felt it (the pandemic) would be in control in six months and now they are saying it will be by April. Unless things really come back to normal, and the economy opens up, we will continue to be affected by these challenges,” Mazumdar-Shaw said.
The challenges include delay in tenders, logistics issues resulting from lack of travel, and inspection delays at facilities. These have delayed approvals of certain biosimilars in the US, the biggest market. Last month, the US FDA deferred granting license to its biosimilar Bevacizumab, which is used for treating lung, cervical and colorectal cancer. Travel restrictions had made it impossible for their representatives to visit the facility. The approval is now expected only in the next fiscal. “We have factored these for the fourth quarter,” Mazumdar-Shaw said.