Retacrit, Hospira’s erythropoietin (EPO) biosimilar, was approved in Europe in December 2007 for the treatment of anaemia associated with chronic renal failure and chemotherapy. While the US does not yet have a working regulatory pathway to approve non-reference biologics, Hospira said it is pushing ahead with its biosimilars pipeline in preparation.
The biopharmaceutical company’s Q1 financial results, published this week, show a 13% increase in R&D spending on the same period last year, reaching $83m (€60m). Hospira’s extra investment was mainly to fund research into Retacrit for submission to the regulators in the near future, said Thomas E. Werner, Chief Financial Officer, in a conference call to investors on Wednesday.
F. Michael Ball, Hospira CEO, said the company had completed two clinical studies on the EPO this month, set to form part of its submission in late 2014 or early 2015 to the US Food and Drug Administration (FDA).
Draft regulations
The company plans to go down the “351(k) pathway,” said Ball, referring to FDA regulations already in use for the approval of new biologics. Under these, a company must provide significant preclinical and clinical data in its submission, and receives 12-year exclusivity on its product. However it is not yet clear how the 351(k) pathway will work for biosimilars, and the FDA is still finalising its guidance.
Ball said Hospira is “in constant communication with them and ensuring that we understand what their expectations are and fine-tuning our studies as we move forward here.”
It is “hard to say,” he added, how long the biosimilars approval process is likely to take, but it is possible this new field could take longer than the usual ten months and reach 18 or 20, making EPO available from late 2016.
The biopharma firm is working closely with the Agency to understand exactly what it will need to do to receive approval, said Ball. “We're ensuring we're doing the types of studies and types of analyses that will do that.” He added he hoped to achieve a “first-cycle approval-worthy submission into the agency - that's really what we're gunning for.”
Inflectra to launch in Western Europe
The company has plans for its other biosimilars, he said, aiming to bring Hospira’s new-to-country submissions up to 250 products by the end of the year.
Ball said he aimed to launch Inflectra (infliximab), known for being the first approved biosimilar mAb, into the Western European market from 2015. It is currently available in Central and Eastern Europe. This quarter also saw Health Canada, the Canadian regulator, approve Inflectra for the domestic market.
Hospira’s net sales for Q1 were $1bn, up 19% from last year, or a 6% increase when adjusted to exclude the impact of the company's 2013 streamlined medical devices programme.