The US Food and Drug Administration (FDA) on Monday approved Biocon-Mylan’s drug Fulphila (Pegfilgrastim) or the biosimilar version of $4 billion drug Neulasta for cancer treatment.
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the US, the first being Trastuzumab or biosimilar version of breast cancer drug Herceptin.
“Pegfilgrastim is a $4 billion dollar in the US and Europe and a huge milestone for Biocon because we are the first to be approved as a biosimilar,” said Biocon CMD Kiran Mazumdar Shaw.
Biocon is expected to launch the drug in FY19.
Since, the drug is a biosimilar, it is not interchangeable with the original drug as it is used to reduce the chance of contracting infections due to low white blood cells in patients receiving chemotherapy for certain types of cancer.
Mylan president Rajiv Malik said the Bengaluru-based Biocon is an important strategic partner and that Mylan would look at opportunities to expand the partnership between the two companies.
Both the companies have already expanded the partnership recently to add two more products, Malik added.
Q: Begin by telling us about the opportunity sizes that this approval will be for the company, the Pegfilgrastim approval?
A: As you know Pegfilgrastim is a very large product. It is a $4 billion product in the US and Europe. For Biocon it is a huge milestone because we are the first to be approved as a biosimilar and obviously we believe that there is a large opportunity and have the first mover advantage as well.
Q: When do you expect to launch the drug, Mylan mentioned launch in the next few weeks, so when would that be?
A: Imminently, because I think it will take some time to just get some of the preparatory work and then I am sure we will be able to enter the market very soon.
Q: You want to give us any kind of timeline at all, I mean would it be in FY19, are you looking at FY20?
A: Absolutely FY19 for sure. I think as Mylan themselves have indicated, it will be in the near future, certainly in the next quarter.
Q: There is a litigation pending with the innovator on two process patents can you tell me what the status of that is?
A: I think I would prefer to Mylan to answer that.
Q: Does it mean if in case the litigation doesn’t get settled it will be an at risk launch?
A: I think Mylan should basically comment on that but having said that the fact that we are willing to launch imminently and I think we are aware of the potential risk and we do not perceive them as high risk.
Q: What will the revenue and profit be like between Biocon and Mylan?
A: It is the same across all biosimilar and we will stick to the same revenue share and profit share. It is basically a profit share not a revenue share.
Q: Assumption is that the company can make up to $70 million annualised from this drug. That is at least what the couple of analyst have told us. Would that be a fair assumption to make?
A: I think there are different assessments made by different analyst but suffice to say that it is a very large opportunity. I think Mylan feels very confident that being a first mover it will have a good advantage and we will obviously make every effort to garner maximum our market share.
Q: What are you anticipating when it comes to competition for example pharma companies, Coherus, Amneal, Intas, Sandoz have all filed and lined up for it?
A: I certainly believe that they will get approval in the near future. But suffice to say that we do have a first mover advantage and I think we have at least, I guess a 6 months advantage over the nearest competitor.
First Published: IST