Following US president-elect Donald Trump’s explosive speech last night where he lambasted the domestic pharma companies for outsourcing work, pharma stocks are likely to be in limelight today. However, any negative impact on generic suppliers here is ruled out, says Kiran Mazumdar Shaw, CMD of Biocon.She said she completely agrees with Trump's view but doesn't see his views affecting Indian pharma.
“I don’t think these are going to be big issues; if Indian pharma companies are supplying these products to the US markets and if there are no US suppliers, which is mostly the case, this doesn’t affect the Indian pharma companies,” she said.
Biocon on Wednesday said the US drug regulator has accepted its partner Mylan’s biologics licence application (BLA) for the proposed biosimilar of breast cancer drug trastuzumab through the 351(k) pathway.
This product is a proposed biosimilar version of Roche’s Herceptin, which is indicated to treat certain HER2-positive breast cancers.
"The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017," Biocon said in a statement.
Speaking about the application, Shaw said that it offers huge potential for the company. Admitting that it won’t give them the advantage that generics enjoy, the upmarket opportunity however is pretty attractive. The market is worth about USD 7 billion globally, she said. “This will make a big difference to cancer patients in the US.”
She hopes that drug approval and marketing efforts will be completed before 18 months. Revenues from it will hopefully start kicking in from FY19, she said.Below is the verbatim transcript of Kiran Mazumdar Shaw's interview to Latha Venkatesh, Sonia Shenoy & Anuj Singhal.
Anuj: Your thoughts on what Donald Trump's has to say last night - pharma companies are getting away with murder - does that worry you?
A: The pharmaceutical companies in the US have been irresponsibly raising their prices and this is a great concern to everyone. However, one thing that Indian pharma companies can certainly not be accused of is raising prices in a big way. Indian generics have done a lot to contain and bring down drug prices in the US and the whole approach of the Indian pharma sector is to address rising drug prices in the US market. So we are hopefully in favour with Donald Trump's views.
Sonia: The other two statements that he made - one with respect to the bidding for these veteran army contracts and second with respect to negotiations as far as medicare is concerned. How would you react to those two statements?
A: It is long overdue that the government is allowed to negotiate drug prices for medicare because it just doesn't make sense that when you are looking for bulk procurement - that you are not legislatively allowed to even negotiate for prices. It doesn't make sense. Therefore, I completely agree with Trump's view. This is long overdue.Latha: So that might be a sentimental negative or even a practical negative for the generic suppliers in India?
A: What you are talking about is the veteran sector but I do not think that these are going to be big issues because if Indian pharma companies are basically supplying these products for the US markets and there are no US suppliers which in many cases is true. I think this doesn't affect Indian pharma companies.
Anuj: Talking about the drug - your partnership with Mylan and the US FDA accepting the application. How big is the potential for this drug?
A: This is a huge potential because this is a breast cancer drug and it's an expensive treatment which we are trying to address with biosimilars and we have got first to file status, not that it gives us the kind of advantage the generics have but the fact is we could be the first biosimilar Trastuzumab launched in the US market. The market opportunity for Trastuzumab is pretty attractive; it is around USD 7 billion globally and this will make a big difference to cancer patients in the US.
Biocon and Mylan would love to make that big difference to patients who actually need this particular drug, we have been making a huge difference to patients in developing economies like India and other countries and we have significantly brought down the prices of this particular drug.
Latha: This is a licence application. How long does it normally take for the drug approval in marketing?
A: It could be anywhere between 18 months. However, we hope that it is going to be less than 18 months and the fact that they have accepted our file is big news because it means that the file is complete, the file is acceptable and they have begun the review process. So it is all very positive news for us.
Sonia: With this your biosimilar portfolio has kick-started on a positive note especially in the US markets. What kind of growth can you expect from this portfolio over the next one-two years?
A: This has been our clear cut strategy for the last several years. We have identified biosimilar as a very large growth trajectory for the company and we have also indicated that we expect these kinds of revenues to start kicking in from FY19 onwards.
Latha: How is the trajectory? Is it exactly like it is in the non-biosimilars that after a couple of trials you can commercially sell it off to others or rope in other manufacturers, do you get money even ahead of 18 months?
A: We have been licensing this particular drug in many emerging markets. As far as we are concerned, Mylan is our commercial partner. Mylan will be front ending this particular marketing and distribution efforts for Trastuzumab and Mylan is a successful marketeer of generics and now biosimilars. So we are confident that we will get a decent share of the available market.
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