Following last week’s recommendation of Sandoz’s Zarzio by the US FDA’s Oncologic Drugs Advisory Committee (ODAC), Hospira has announced it has submitted a Biologics License Application (BLA) for its proposed biosimilar to Amgen's Epogen and Janssen’s Procrit.
The application was filed in December under the 351(k) approval pathway and while there is no requirement from the FDA to publicise the submission, Hospira spokesperson Julie Ferguson told Biopharma-Reporter.com the firm “decided to wait to announce the filing until after the holidays,” before making it public.
“This is Hospira’s first submission for a biosimilar in the United States,” she continued. “We expect notification of acceptance for filings about 60 days after submissions. Hospira also expects a complete response to our application within 10 – 24 months, but we cannot guarantee that we will receive an approval within any particular timeframe.”
The biosimilar has been available in Europe since 2008 for the treatment of anemia associated with chronic renal failure under the brand name Retacrit.
However, even if approval is granted Retacrit may not be the first biosimilar launched by Hospira in the US, as Ferguson said the firm holds exclusive rights to market Inflectra – a version of Janssen’s Remicade (infliximab) - in the country through a recently expanded partnership with South Korea’s Celltrion.
Despite an ongoing lawsuit with Janssen, Celltrion has said the FDA could approve its monoclonal antibody biosimilar by August 2015, barring any setbacks.
Amgen's concerns
While applications from Sandoz, Hospira and Celltrion will not guarantee a biosimilar breakthrough in the US, these actions are being closely followed by both reference biologics and biosimilar makers.
Amgen falls into both categories; though the recommendation of Zarzio and submission of Retacrit could be seen to threaten the firm’s sales of Neupogen and Epogen respectively, the company has nine of its own biosimilars in development.
“Amgen, as a developer of both innovative biologics and biosimilars, supports a science-based, patient-centric, regulatory framework for all biosimilars,” a spokesperson told this publication. “High-quality, reliably supplied biosimilars have the potential to offer additional choices to patients and other key stakeholders.”
At last week’s ODAC meeting, Richard Markus, Vice President of Global Development for Amgen’s biosimilar portfolio urged the FDA to adopt “policies that ensure data transparency, manufacturer accountability, and product traceability,” in its approach to biosimilar approval.
These included ensuring such drugs have distinguishable non-proprietary naming, product labelling, post-marketing studies, as well as considering policies related to interchangeability designations.
Without recognising these need he warned by 2020 there could be as many as 40 biosimilars plus reference products that “need to be accurately tracked and traced so that the manufacturers can independently be accountable for the safety, purity and potency of their products.”