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On track for launching Semglee in US in Q2FY21: Biocon’s Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Biocon and its Mylan today received the US FDA’s approval for their insulin glargine injection Semglee, used for Type 1 and Type 2 diabetes.

Biocon and its Mylan today received the US FDA’s approval for their insulin glargine injection Semglee, used for Type 1 and Type 2 diabetes.

The nod comes through soon after the US Patent and Trademark Appeal Board (PTAB) rejected a challenge from Sanofi, which said Semglee infringes upon the patents for its product Lantus, also an insulin glargine injection.

“All the decks are cleared, we have won all the pending litigations. That paves the way for an unencumbered entry into the US market,” Biocon CMD Kiran Mazumdar Shaw told CNBC-TV18. “We already said that we were going to launch in Q2 of this fiscal and we are on track for that,” she further mentioned.

“We have already been approved in Europe but entering the US market was extremely important for Biocon. So we believe that this could now open the way to a very large business opportunity for Biocon in the years ahead,” she said.

Shaw added that glargine was a $8 billion market globally, with the majority of it being in the US.

“We are confident that we will get a very decent double-digit plus market share in the US before long. The US opportunity is about USD 6-7 billion,” she said.

The Biocon chief also talked about the COVID-19 pandemic, saying the government must focus on bringing down the mortality rate.

She added that the economy could not afford another lockdown and it would not help also.

“Implementing a lockdown [now] is like ‘shutting the stable after the horse has bolted,” she said.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
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nifty bank ₹1,318.95 -1.95

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 5 Minutes Read

Getting ‘voluntary action indicated’ status for Malaysian unit a key development, says Biocon’s Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Our public health system has to be improved and there is a lot of opportunity for us to build a very robust healthcare ecosystem, said Kiran Mazumdar Shaw, CMD, Biocon.

The USFDA has issued 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 a 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 because 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.

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.”

“So, we do have an opportunity to play very strongly in this segment. It is a USD 7 billion business globally and in US itself, it is a USD 4 billion business. So from that point of view, it has a huge opportunity and it is growing. With biosimilars, the 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 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 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 USD 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 a very close cooperation going on 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, adding 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 opportunity for us to build a very robust healthcare ecosystem,” she stated.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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 5 Minutes Read

USFDA observations to Biocon’s Malaysia facility not serious, say analysts

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of the company’s insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and 21, 2020.

The observations received by the Biocon from the US drug regulator for its Malaysia plant are procedural and not serious, analysts said.

The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of company’s insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and 21, 2020.

At the conclusion of the inspection, the agency had issued a Form 483 with 3 observations.

CNBC-TV18 has accessed Form 483 for Biocon.

These three observations basically, according to analysts, look manageable at this point in time.

Earlier, the company told CNBC-TV18 that the observations were procedural and there were no repeat observations as well in the Form 483.

Analysts believe this is a positive development for the company and it does not look like anything as serious as data integrity.

Meanwhile, the street will await the target action date for insulin Glargine in the US which is June 2020. This means by then the company has to apply or USFDA has to give a reply to Biocon with regards to this particular application.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Previous Article

Oil Fluctuates as Traders Assess China’s Vow, Unrest in Libya

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Biocon Q3 earnings preview: Key things to keep in mind

Biocon

Bengaluru-based Indian biopharmaceutical company Biocon is set to declare its Q3FY20 numbers today. Here are the key things to keep in mind ahead of the results:

The revenue is expected to grow by around 12 percent.

EBITDA is likely to be up around 23 percent.

Margins are expected at 27 percent.

Profit is likely to grow at a rate of 10 percent.

For this quarter, the impact of the launch of Trastuzumab will be seen.

Among the key things to watch out for will be the branded generic segment.

Management commentary with regards to insulin Glargine will also be crucial.