Hospira's Generic Epoetin Alfa Receives Supplemental Approval in US
This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa).
Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.
FibroGen has reported top-line results from a pooled analysis of its phase 3 roxadustat safety data. Shares in FibroGen plummeted following the readout as the wording of the number-free statement and subsequent conference call raised concerns about the safety of the kidney disease drug.
AstraZeneca and FibroGen say they are preparing a US filing of roxadustat for anaemia in chronic kidney disease after reporting cardiovascular outcomes data from phase 3 trials.
Hospira`s Retacrit (Epoetin Alfa-Epbx) Receives Approval in US
Pfizer on Wednesday announced the U.S. launch of its third biosimilar product, creating a new market threat to Amgen's Epogen and Johnson & Johnson's Procrit.
Sandoz's Binocrit (epoetin alfa) Receives Approval in Europe
Medice Arzneimittel Pütter's Abseamed (epoetin alfa) Receives Approval in Europe