Tag: Pegfilgrastim

Here’s why Lupin stock traded higher today

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

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Lupin was trading higher on the back of some positive news flows regarding Albuterol and Pegfilgrastim.

There are a couple of news points with regards to Lupin. One of them is that the USFDA has accepted Lupin’s application for the cancer biosimilar Pegfilgrastim.

Separately, data from the US indicates that there is a ramp-up for the Albuterol inhaler for both Cipla as well as for Lupin.

The company is targeting nearly 20 percent market share in Albuterol generic inhaler versus the current market share of nearly 8 percent.

Watch the accompanying video of CNBC-TV18’s Ekta Batra for more details.

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Coronavirus concerns: Need to take immediate steps to address possible shortages if crisis extends, says Biocon

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

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Various stakeholders of the pharmaceutical industry along with Kiran Mazumdar Shaw, CMD, Biocon met government officials yesterday to discuss the supply concerns if any due to coronavirus outbreak.

“We had a very useful meeting yesterday chaired by Amitabh Kant. We had all the various stakeholders from industry and government involved and we did a fairly good assessment of what the state of preparedness should be,”  said Mazumdar Shaw in an interview with CNBC-TV18.

“At this point in time, I do believe that we are quite safe for the next several months but we all realise that we have to basically make sure that we take some immediate steps to start addressing possible shortages if this coronavirus crisis extends beyond six months,” she said, adding that the government said they would do everything to free up the hurdles faced either by closed plants or existing plants, which wish to produce certain products that they don’t currently produce in case the crisis extends.

“Going forward we need to focus on producing many of our requirements at scale and we need to regain our lost position in terms of the active pharmaceutical ingredients (APIs) and even intermediate production,” said Mazumdar Shaw.

Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance had told CNBC-TV18 that as of now there was no supply disruption and they were good at least for the next four-five months, so there won’t be any impact on drugs. However, he mentioned that raw material prices could go up further.

When asked about the situation with regards to supply and raw material prices, Mazumdar Shaw said, “That is a pretty realistic statement. If this continues beyond six months, we do have to worry about the impact. For now, we are okay. I also believe that because of this crisis, prices are going to go up in many cases but that is okay because even if the prices do go up, they won’t significantly impact drug prices.”

“India has a huge opportunity and this should not be a lost opportunity because there are opportunities in many sectors but pharmaceutical sector is a big one and we should focus on that,” she further mentioned.

Talking specifically on Trastuzumab, she said, “We are very gung-ho on this product. We have had a very successful launch with Pegfilgrastim, and Mylan is very confident that it can repeat that success with Trastuzumab as well. I believe we should be able to have a very successful launch and market share.”

When asked about inspections and observations, she said, “We have to understand that USFDA or any regulatory inspections are a way of life for us and with every inspector there are going to be observations and we have to address these observations through plans. So, every company should get used to that. We look at it as a continual improvement opportunity for the company.”

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Launch of Trastuzumab in US market offers a sizeable opportunity for Biocon & Mylan, says Kiran Mazumdar Shaw

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

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Biocon and Mylan have launched a cancer drug Trastuzumab in the United States. The size of the drug is USD 2.5 to 2.8 billion in the US market and Biocon is estimated to make USD 70 to 100 million in peak sales.

Speaking at length about this development Kiran Mazumdar Shaw, CMD of the company said they entered the US market after being the first to be approved but Amgen (pharma company) launched Trastuzumab at risk. Apart from Amgen there are two other approvals as well, she added.

“However, we believe that the space is still not crowded. We believe that this is a very important segment for us. The market dynamics are about ensuring access to this very important breast cancer drug and we believe that Mylan and Biocon are committed to this end and we believe that we are able to offer affordable access to this lifesaving breast cancer drug,” she added.

“We believe we will have a pretty major impact on this market opportunity and can get a sizeable share of the market despite 4 other competitors that we will have to contend with,” she further said in an interview with CNBC-TV18.

“We have a profit share arrangement with Mylan and we believe that the opportunity is sizeable for both Myland and Biocon,” she said, adding that they would be able to share more accurate estimates as they enter the market and see how they fair.

Not committing to any number, she said  there are estimates that analysts have assessed from the market size and market dynamics.

She said they got both the dosage forms of 440 and 150 mg, which puts them in a strong position to garner market share. “The 150 mg formulation is the dominant formulation, which Biocon has in terms of approval,” she added.

On biosimilars front, the CMD said, “This is our second biologics to be marketed or commercialized in the US. The first being Pegfilgrastim. So we do have a growing portfolio of biosimilar antibodies for cancer. The next being Bevacizumab. So as a company Mylan and Biocon are well positioned to be strong player in this whole oncology space.”

We have a significant presence in some of the among emerging markets for Trastuzumab , said Mazumdar Shaw.

Talking about their sales target of USD 1 billion for biosimilars  by FY22 she said, “At the moment we are very much on track. We believe that we can get even more confident once our products enter the markets and we see the kind of market share we are garnering, but at this point in time we remain confident of hitting that target.”

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

Biosimilar drug Pegfilgrastim a large opportunity, says Biocon

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

Listen to the Article (6 Minutes)

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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

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