In focusing on individual drug shortages, the FDA is missing opportunities to proactively prevent and mitigate shortages in general, according to the Government Accountability Office (GAO).
Contradicting FDA reviews could have The Medicines Co. swinging when its cangrelor steps up to the plate at the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting Wednesday.
A culturing process designed to determine the growth and biological characteristics of the resulting cell population is enough to render stem cells a drug subject to FDA manufacturing and labeling regulations, a federal appellate court said this week in a ruling upholding a permanent injunction against Regenerative Sciences LLC’s Regenexx-C, a stem cell product used as an alternative to surgery for various orthopedic conditions and diseases.
With the FDA expected to approve its first biosimilar within a year or two, how to name the follow-on biologics has passed from an academic debate to a must-do proposition. Since sponsors must include the name in the dossier when they submit a biosimilar application, those that are getting close to filing need to know pretty quickly how the drugs are to be named, Sumant Ramachandra, senior vice president and chief scientific officer at Hospira Inc., told BioWorld Today.
Seeing the biosimilar debate as a way to improve pharmacovigilance for all biologics, several biosimilar makers are now pushing for state notification regulations that would lead to transparent and more accurate patient health records.
It’s amazing what a difference a decade can make. In 2003, Japan and Singapore were the only countries in the Asia-Pacific region that exported more than $1 billion worth of drugs to the U.S. Japan shipped about $2.9 billion worth of “medicinal, dental and pharmaceutical preparations,” and Singapore exported drug products valued at nearly $1.6 billion, according to the U.S. Census Bureau.
With an eye on enhancing biologic competition, the FTC is diving into some of the issues that will shape the biosimilar market in the U.S. But the Congressional Research Service (CRS) isn’t holding its breath as it waits for the competition to hit.
If Congress wants a healthy biopharma sector that continues to produce innovative therapies to cure the world’s ills, it needs to ensure that those therapies have strong patent protection.
While still a long way from solving the problem of how to name biosimilars, a World Health Organization (WHO) expert group is looking at a hybrid proposal that straddles the fence between conflicting calls for unique or shared international nonproprietary names (INNs).
