Tag: Trastuzumab

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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Crucial weeks ahead for Biocon amid growing competition in trastuzumab market, regulatory inspections

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

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February and March are going to be important months for Biocon when it comes to news flow and triggers for the stock. One of the near term events will be pharma giant Pfizer launching its version of cancer biosimilar trastuzumab on February 15. Biocon in partnership with Mylan launched its version of trastuzumab, branded as Ogivri, in December 2019 in the US. Trastuzumab is the biosimilar version of breast cancer drug Herceptin by Roche. Pfizer’s launch will mean additional competition for Biocon in the trastuzumab market which has already seen Amgen launch its version ‘at-risk’ in July 2019.

Analysts believe Amgen has around 15 percent market share in the trastuzumab market and besides Pfizer more competitors are expected in 1HCY20. Other companies that have filed for the drug besides Pfizer are Celtrion, Teva, Samsung and Merck. Despite the impending competition, analysts are confident about Biocon ramping up the trastuzumab market share. Estimates are Biocon-Mylan could gain 6-9 percent share in the first year and 14-15 percent in the second year. The primary reason for the optimism is because trastuzumab is a large market with a limited number of players. The market size is $2.5 billion with around 3 to 4 companies selling the drug. According to them, how much Biocon can make will depend on how much the prices will reduce. Estimates are prices can reduce up to 30-40 percent in the first year, followed by 50 percent plus in the second year. The range on how much Biocon can make in the first year is wide from $60 million all the way to $120 million.

Regulatory inspections 

The other important triggers to watch for will be on the regulatory front. Biocon had communicated to investors and analysts in the Q3 earnings call that the firm is expecting its Malaysian facility to be reinspected by the USFDA in February 2020. This inspection is particularly important as insulin glargine, a biosimilar drug for diabetes, branded as Semglee by Biocon, is filed from the Malaysian plant. The Malaysian facility was earlier inspected by the USFDA on account of approval for insulin glargine in July 2019. The USFDA in July 2019 issued 12 observations to the facility. The observations resulted in queries from the USFDA in the form of a Complete Response Letter (CRL) to the company on insulin glargine. The CRL mainly pertained to the observations issued to the Malaysian facility as per analysts. This meant that in order to receive approval for insulin glargine the USFDA would have to clear the Malaysian facility mostly with a re-audit. This reinspection is now expected in February making it crucial to the future of insulin glargine.

The Target Action Date or the time by which USFDA is going to reach a decision on Biocon’s application for the diabetes drug is June 2020, another important month to keep in mind. The company is confident of a mid-2020 launch and says it has been working with the USFDA on the approval and the Malaysian plant clearance. Biocon has launched Insulin glargine in other markets such as Australia in October 2019.

Lastly, the other important piece of news to watch for in the next few weeks will be the details of five observations issued to Biocon’s API facility in Bengaluru. The inspection was both a Pre-Approval Inspection that is specifically for a product and a general inspection of the facility. The inspection was conducted from January 20 to 24. While Biocon has generally had a good track record when it comes to compliance, analysts are particularly keen on knowing about these observations.

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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