Hospira Submits New Biologics License Application to FDA for Proposed Epoetin Alfa Biosimilar
Hospira, Inc. has submitted a Biologics License Application (BLA) to the FDA for Retacrit, a proposed biosimilar to Amgen's Epogen (epoetin alfa) and Janssen's Procrit (epoetin alfa).
The biosimilar application was submitted on 16 December 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
"As one of the first companies to submit a biosimilar application in the US, we are proud to be a leader who can help our country's healthcare system decrease unsustainable costs by embracing a new frontier in medicine," said Sumant Ramachandra, senior vice president, chief scientific officer, Hospira. "Hospira is proud to build upon our global experience of providing biosimilars to patients across the world."
Related News
-
News Novartis signs US$3.2 bn subcutaneous delivery deal with Alteogen
Swiss pharma giant secures access to Korean biotech's ALT-B4 hyaluronidase platform in milestone-heavy agreement, marking Alteogen's fourth major licensing deal of 2026 as competition intensifies in the subcutaneous drug delivery space.
-
News Women in Pharma: The philosophy of pharmaceutical leadership
In this latest instalment of our Women in Pharma series, we sit down with Clarissa Sowemimo-Coker, Chief Strategy Officer at Ambrose Healthcare and CPHI Middle East Advisory Board Member.
-
News The PSCI Supplier Partnership - Collaboration for Responsible Supply Chains
About the Pharmaceutical Supply Chain Initiative The Pharmaceutical Supply Chain Initiative (PSCI) is the leading, member-led association for pharmaceutical companies working collaboratively to build responsible supply chains. Founded in 2006 and es... -
News AstraZeneca shares plunge 8.9% after reports of BMS talks
Britain's largest drugmaker lost more than GBP£17 billion in market value following reports of preliminary merger discussions with Bristol Myers Squibb that could create a pharmaceutical giant worth nearly US$400 billion, though investors rem... -
News GSK announces £400 million investment in new Cambridge R&D centre
Pharmaceutical giant to establish flagship research facility on Cambridge Biomedical Campus as part of strategic pipeline acceleration
-
News The CPHI Sustainability Summit - Where Conversation Becomes Collaboration
The Report Was Never the Destination - “The future of pharmaceutical sustainability won’t be shaped by individual organisations working in isolation. It will be shaped by partnerships, shared expertise and the willingness to work diffe... -
News Trump's generic drug tariffs set to reshape global pharmaceutical supply chains
The US president has announced plans to impose tariffs of up to 200% on imported generic medicines from August 2028, giving manufacturers a two-year window to establish domestic production facilities. The move threatens to upend a global supply chain t... -
News Building Safer, More Responsible Pharmaceutical Supply Chains: PSCI Global Audit Insights
The Pharmaceutical Supply Chain Initiative (PSCI) has released its seventh annual Audit Findings Analysis Report, offering unprecedented insights into supplier practices across the global pharmaceutical and healthcare industry.With a record-breaking 24...