India’s Biocon has pulled its EU application for a Herceptin biosimilar while it hustles to get its manufacturing in order but said today it should be in a position to resubmit the paperwork to authorities next quarter.
Biocon and biosimilar partner Mylan, which had expected to be first to market in the EU with a copy of the blockbuster cancer med, ran into a roadblock last month when the European Medicines Agency found issues with its product plant in Bangalore. It told the two that a follow-up inspection would be in order before the Herceptin knockoff and a biosimilar of Amgen’s chemo companion drug Neulasta will be considered for approval.
In a filing today, Biocon said the EU’s request for withdrawals and resubmissions linked to this reinspection was routine. It said its plan to fix issues of concern at the plant is on track to be complete by the end of this quarter and “it is our intent to seek reinspection and resubmission thereafter.”
It reiterated that French inspectors following an inspection in March approved its drug substance plant that is making the APIs for both biosimilars.
In the U.S. at least, these kinds of manufacturing-related issues have not always been resolved so quickly. AstraZeneca has had its application sidelined twice for ZS 9, a potential blockbuster treatment for hyperkalemia that was the target of the U.K. drugmaker’s $2.7 billion buyout of ZS Pharma in 2015. The second rejection came 10 months after the first.
A week ago, Valeant Pharmaceuticals' NDA for an eye drug was denied a second time because of manufacturing issues at a Bausch + Lomb plant. That came a year after its first application was snubbed.
Other drugmakers would love to get to the market first with a biosimilar of the giant seller. Samsung Bioepis, a joint venture between South Korea’s Samsung BioLogics and Biogen, has an application in to the European Medicines Agency, and Celltrion and Pfizer's Hospira unit are also said to be preparing to file for approval of their own versions of the big-selling brand.
Any delay is a big deal for Roche. Its EU patents on Herceptin expired in 2014, but it remains the Swiss group's third-biggest drug with sales of about $7 billion last year, about $2 billion of that coming from the European market.
Last year, Roche's head of pharma, Dan O'Day, said he did not expect biosimilars of the cancer drug to reach Western markets until late 2017.