The USFDA has issued an Establishment Inspection Report (EIR) with 'voluntary action indicated' status to Biocon's Malaysian unit in terms of production of Glargine.
Sharing further details, CMD of the company Kiran Mazumdar-Shaw said, “This is an important EIR that we have received and it is good because it makes us feel confident that we will get the approval sooner than later.”
In terms of the timeline, she said, "We have always said that it will be in the first half of this year. So, that is what we stick by."
With this entire COVID-19 crisis, one does not know when the US markets will open for business. So we have to be a bit realistic, she said, adding that they were glad the inspection went well.
"I hope that we get the approval soon but in terms of the launch, we have to be realistic; we need to wait-and-watch and see how things progress because the US is going through a very bad phase,” she said in an interview with CNBC-TV18.
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When asked about the market size, Mazumdar-Shaw said, “Post COVID-19, there will be a huge effort to bring down healthcare costs and biosimilars are certainly going to be extremely important in this effort. I believe insulin therapies are also going to play a very important role in cost-cutting and biosimilar glargine, insulins and others are going to be extremely important."
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"So, we do have an opportunity to play very strongly in this segment. It is a $7 billion business globally and in the US itself, it is a $4 billion business. So from that point of view, it has a huge opportunity and it is growing. With biosimilars, access to insulin glargine is much larger. We have a very important role to play in providing affordable access to glargine,” she said.
When asked if the number of private labs conducting COVID-19 tests would be extended and the challenges that the industry is facing in India, she replied, “Including the private labs has been a very good move on part of the government. It should have been done sooner than this. The challenge is that the state government’s legislations are coming in the way. The kit issue is being resolved because a number of kits are now being produced and I don’t think we will have an issue with a number of kits, as more kits are being approved."
"The biggest worry is the way state governments are restricting private labs from testing. In Karnataka, we have cleared the way. Maharashtra has become extremely difficult. All the state governments, Maharashtra, Telangana, Gujarat, West Bengal, they have come on very heavily on to private labs. If you don’t allow private labs to test large numbers, you are defeating the purpose of including private labs into this testing arena,” she cautioned.
Talking about their biologics business target of around $1 billion by FY22, she said, “It is two years away. We are hoping that our business will go according to plan. There has been a lull right now because of logistics issues. I am hopeful that the COVID-19 crisis will pass sooner than later. We will work towards that target but more than anything else, this is a time for biosimilars to have a huge impact on global healthcare and that is why I remain very confident that we will have a very big role to play.”
“There is very close cooperation between the government, the Centre and the private sector whether it is on the research front, whether it is on the private testing front etc. I am very pleased with that. We are all working towards developing vaccines, therapies and new antibody-based serological testing, so there is a lot of that kind of work going on," she said,
She added that what COVID-19 crisis has shown us is that we have to focus on these very important areas. Infectious diseases have been neglected and ignored for too long.
"Moreover, our public health system has to be improved and there is a lot of opportunities for us to build a very robust healthcare ecosystem,” she stated.
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