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).
The Patient-Centered Outcomes Research Institute (PCORI) responded to criticism about how it’s spending its research dollars with a reminder that its 10-year mandate is not just for comparative clinical effectiveness research (CER).
Cleveland Biolabs Inc. (CBLI) learned the hard way that there are limits to how much the U.S. government is willing to spend to develop drugs it hopes it will never use.
The Supreme Court shot down the Federal Circuit’s attempt to shift the burden of proof from patent holders to licensees when they seek a declaratory judgment in some patent disputes.
More than a year after a federal appeals court ruled that prosecuting a former pharma sales rep for off-label marketing violated his freedom of speech, the FDA continues on a collision course with the First Amendment.
