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).
Since Biocon-Mylan is expected to be the first company to launch the drug in the US, it will have a first mover advantage.
Biocon expects to launch the drug in FY19. Mylan said they are anticipating a launch in coming weeks.
Mylan and Biocon are in a partnership to develop and commercialise a raft of highly complex biotechnology-based drugs.
Analysts said the opportunity will really come through in FY20. In terms of numbers, the street is excited.
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.
Bengaluru-based drug maker Biocon and US-based Mylan is having a profit sharing agreement on all biosimilars and the same applies in the case of Pegfilgrastim.
While the exact profit sharing ratio is not known, based on a limited competition scenario initially, Biocon is expected to make over $50 million revenue from the drug in one year, with some analysts estimating it to 25% of Biocon’s FY20 profit.
On the other front, Mylan is facing a litigation on two process patents, which is currently pending in the US.
If Mylan doesn’t settle on this litigation, then it will be an at-risk launch. It means, Biocon-Mylan launching the drug with an ongoing legal case.
Apart from revenue, profit and litigation this approval should be a feather in not only Biocon’s hat, but one for the Indian pharmaceutical industry.
It also shows the the Biocon's ability to solve regulatory issues successfully. The USFDA giving approval for the biosimilar means it is not perturbed by the seven observations Biocon received in a pre-approval inspection for Pegfilgrastim that took place at its Bengaluru facility in April.
The approval reinforces the capabilities of Biocon in the biosimilar space and its ability to create a niche in a lucrative market.It probably gives confidence to the street on upcoming opportunities Biocon has in the biosimilar space – Insulin Glargine for one and the likes of Adalimumab or biosimilar version of Humira to just name a few.