With the approval of aspart, Biocon says it will become the first company to receive approvals for two interchangeable insulin drugs in the US, helping it make a strong entry into that market. This also proves that the company has the science and vertical integration required to get to the US market, it said.
“Biocon has demonstrated the ability to take very complex biosimilars to the US market, first with trastuzumab, pegfilgrastim and Semglee, and soon I hope bevacizumab and aspart. To take five products to the US and succeed is not a joke,” Kiran Mazumdar-Shaw, executive chairperson at Biocon, said in an interaction with ET.
“We will be the only company in the US with two interchangeable insulins and therefore it sets us up for a big foray in insulins. I believe that it may end up being a slightly lower-margin business than antibodies, but certainly it is a very attractive business,” she added.
Mazumdar-Shaw said Biocon’s ability to get approvals for two interchangeable insulins in the US is a major milestone, and that it will add recombinant insulin to the offerings in the country, making for a full-basket of insulin offerings from the company there.
The success of Biocon in getting US regulators to approve its insulin drugs is an example of the company’s growing clout in the biosimilars market, which Mazumdar-Shaw said is a “future-proof” business with more opportunities for growth emerging from it. She added that US approvals also set the stage for wider global adoption.
“We have a first-mover advantage because right now we’re the only company from India that has built the credibility that we have the science and the vertical integration that is required to get to the US market. The US market is the barometer for this. You can be in any other market, but to be in the US market is the hallmark of success,” she said.
It also fits into India’s pharmaceutical story, which recently received a huge recognition in managing to support the country’s administration of 1 billion Covid-19 vaccine doses. A vast majority of the vaccine doses administered by India were manufactured at home, without having to rely on imports at a time when there is a global shortage.
“It was developed here, produced here and used to vaccinate our population, so that’s fantastic,” said Mazumdar-Shaw, referring to Covid vaccines.
