News
G-CSF biosimilars – World Marrow Donor Association position
2013-05-06 The World Marrow Donor Association (WMDA) has expressed its position on the use of granulocyte colony-stimulating factor (G-CSF) biosimilars in healthy donors in an article… Read More »
Prescribing in Scotland increases but drug costs drop
2013-05-03 Spending on medicine in Scotland was 11% less in 2011–2012 compared to spending in 2004–2005. This is despite the volume of prescriptions increasing by 33%… Read More »
Generic Doxil approval may help alleviate drug shortages
2013-05-01 FDA announced on 4 February 2013 that the agency had approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Liposomal… Read More »
Assessment of biosimilarity under the BPCI Act
2013-04-29 The Biologics Price Competition and Innovation (BPCI) Act defines a biosimilar as a product that is highly similar to the reference product notwithstanding minor differences… Read More »
Conflict-of-interest policies reduce brand-name prescribing
2013-04-26 Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who train in… Read More »
Biotech firms try to limit biosimilar substitution in US
2013-04-24 FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the… Read More »
Draft revision of biosimilar low molecular weight heparin guideline
2013-04-22 EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight… Read More »
China’s SFDA to fast-track high-priority generics
2013-04-19 China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation… Read More »
FDA gives details of generic drug user fees
2013-04-17 FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012… Read More »
Overview of research on G-CSF biosimilars in 2012
2013-04-15 Period: January to August 2012 A life-threatening complication for patients undergoing chemotherapy is febrile neutropenia, involving a loss of neutrophils (white blood cells) and fever.… Read More »
