Will Hospira’s Epogen Biosimilar Follow Sandoz’s Filgrastim Playbook?
This article was originally published in The Pink Sheet Daily
Executive Summary
Hospira’s 351(k) application includes two comparative safety and efficacy studies and two open-label long-term safety studies for epoetin biosimilar.
You may also be interested in...
Lessons From The First Biosimilar MAb Launch In Europe
Physicians appear more willing to prescribe Hospira’s Inflectra, a biosimilar version of J&J’s Remicade, to new patients in countries in Europe where it is available, but less inclined to switch patients already taking the brand. The company’s experience in Europe could offer lessons for manufacturers looking to bring biosimilars to market in the US.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.