BBL’s CEO and managing director Shreehas Tambe outlined the rationale behind the pause on the rHI program, starting out by underscoring the Indian firm’s commitment to insulins globally, particularly in the US as well.

While glargine has been a success, for aspart the company is awaiting an FDA re-inspection at its insulins manufacturing facility in Johor, Malaysia following an Official Action Indicated (OAI) classification by the agency in October last year.

“We continue to engage with the FDA and have had progressive discussions regarding our Malaysia OAI status and biosimilar aspart BLA. The next step would involve a site inspection in Malaysia in the near term,” Biocon CEO Bains said.

BoFA Securities said the silver lining in management commentary was the Malaysia facility awaiting re-inspection, which was earlier than its expectation. “We believe this could be a key catalyst for the stock to provide visibility on aspart approval (BofAe 2HFY25),” it added.

Tambe explained that rHI isn’t one product. – “it’s three different products” and also referred to the evolving policy landscape in the US.

“We’ve filed for insulin R. There is also insulin NPH, there's also insulin 70/30, which is a mix and you have to develop all three as different products and do clinical trials for all of them, at least Phase I,” he noted.

That said, the three products put together are estimated to be a little under $1bn as a franchise in the US.

“Now, in light of the recent policy changes, I think it's important to see how this shapes up, and which is why we have paused that [program]. Right now, the policy advisory is that it's $35 no matter which insulin is prescribed as a co-pay. So, we just want to make sure that we understand this, see how the market evolves,” Tambe explained.

Under the US Inflation Reduction Act, insulin cost-sharing will be capped at $35 per month beginning in 2024. Earlier, an analysis by RAND Health Care noted that in 2022 US prices for insulin products were nearly 10 times as high as those in 33 Organisation for Economic Co-operation and Development (OECD) comparison nations.

“Average gross prices in the US were more than 10 times prices in France and the UK; nearly nine times prices in Italy; more than eight times prices in Japan; about seven times prices in Germany; and more than six times prices in Canada,” indicated the study, contracted by the Office of the Assistant Secretary for Planning and Evaluation.

BBL’s CEO underscored that the company has “two great products” on the market in the space that are gaining market share and customers.

“So, we first want to capitalize on the investments we made before we can embark on further development and take on further cost,” the CEO emphasized.

Biocon Eyes 'Foothold To Stronghold' For (b)Humira In US, Pauses RH-Insulin Program

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