FDA clears cancer drug by Biocon-Mylan

FDA clears cancer drug by Biocon-Mylan

4:59 AM, 11th June 2018
Biocon CMD Kiran Mazumdar-Shaw. (TNN file photo)
Biocon CMD Kiran Mazumdar-Shaw. (TNN file photo)

In a major milestone for domestic company Biocon Limited, the US Food and Drug Administration (USFDA) has approved its biosimilar Pegfilgrastim for cancer, co-developed with Mylan NV.

Pegfilgrastim (Fulphila) will represent a more affordable treatment for oncology patients, says Biocon CMD Kiran Mazumdar-Shaw in an interview with TOI. Fulphila, which will have the first-mover advantage in the US, is expected to contribute to Biocon’s revenue in FY19, as well as to its profits through a profit-share arrangement with Mylan. Excerpts:

What is the timeline of launch of Pegfilgrastim in the US and other developed markets?

Our partner Mylan is in preparation to launch Fulphila in the coming weeks, giving cancer patients in the US the first alternative and affordable treatment option to branded Pegfilgrastim. Regulatory reviews of our biosimilar Pegfilgrastim dossier in the EU, Australia and Canada are progressing well. We cannot provide specific timelines for the launch of our biosimilar Pegfilgrastim.

What kind of competition is expected in Pegfilgrastim in the US?

There is a queue of a few players developing this product. However, Biocon-Mylan’s Pegfilgrastim is the first biosimilar to be approved by the USFDA. As Fulphila is the first FDA-approved biosimilar Pegfilgrastim, we will have a first-mover advantage.

I understand that the US market for Pegfilgrastim is over $4 billion. What upside in terms of revenue & profit is expected on account of the biosimilar this year or going forward?

As you know, Mylan has the exclusive commercialisation rights in the US for biosimilar Pegfilgrastim. The sales of Fulphila will add to Mylan’s top line, while Biocon has a profit-share arrangement with them. Biocon will manufacture the product at its facilities in Bengaluru and supply to Mylan. These sales will contribute to our previously guided revenue target of $200 million from the biologics business for FY19.

How does the pipeline look for biosimilars in the US?

We have been developing a high-value portfolio of biosimilar mAbs and insulins in partnership with Mylan for the US market. In the past few months, we have made significant progress with milestone approvals for our biosimilar versions of Trastuzumab and Pegfilgrastim in the US. Our biosimilar Pegfilgrastim is the second from Biocon-Mylan’s joint portfolio to receive approval in the US. It is one of the 11 biosimilars being co-developed with Mylan for the global marketplace.

What’s the update on Trastuzumab for the US market?

Ogivri is the first FDA-approved biosimilar to Herceptin and the first from Mylan and Biocon’s joint portfolio approved in the US, in December 2017. Our partner Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licences for its Trastuzumab product from Genentech and Roche last year. We believe this enables Mylan to commercialise biosimilar Trastuzumab in various markets globally at an appropriate time. We would not be able to comment on any specific launch timelines.




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