AAM
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.
Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.
The new guidance says comparative clinical trials are not a prerequisite for all biosimilars, a notable step for the FDA, but the commissioner added that biosimilar prices should be significantly lower than the reference product at launch.
Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.
US FDA commissioner says the agency plans to look for clinical trial fraud in applications using artificial intelligence, in part to find problems sooner.
The payor’s multiyear plan to ditch the traditional PBM model and use multiple vendors has drawn a lot of skepticism from other actors in the health care system, but Blue Shield is hoping that it can help give policymakers some momentum, VP Lum tells the Pink Sheet.
As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.
With the first US Humira rival having just hit the market and biosimilars seeing increasing adoption overall, Craig Burton – executive director of the AAM’s Biosimilars Council – says that the US biosimilars market is ‘doing better, but we still have improvements to make.’
With the first US Humira rival having just hit the market and biosimilars seeing increasing adoption overall, Craig Burton – executive director of the AAM’s Biosimilars Council – tells Generics Bulletin that the US biosimilars market is ‘doing better, but we still have improvements to make.’
AAM hopes everyday voices – and Mark Cuban’s – will help policymakers appreciate the contributions that generic drugs make to the healthcare system. ‘We need to create an emotional connection,’ a campaign designer said.
Prompted by an Executive Order on drug price competition, the cross-agency training aims to ensure that the Patent and Trademark Office is aware of all information that FDA makes available.
Vaccine makers get all the credit (among those who think any credit is due) for ending the pandemic, but generic sponsors want to remind policymakers that their plants stayed open during the worst of COVID-19 to ensure that hospitals were stocked and medicines for chronic conditions didn’t run short.
The new chair of the US generics association talks to the Pink Sheet about how to make sure that policymakers don’t take the industry for granted.
With the mask mandate now lifted for air travel and the grimmer milestone of one million Americans dead from COVID approaching, the Pink Sheet looks back at the generic trade association’s annual meeting to see what business gatherings may look like going forward.
Unable to predict which divestures will be required by the EU or the US FTC, firms will instead look to private equity, their organic pipeline, or partnerships for growth, CEOs forecast on the last day of the generic trade association’s annual meeting.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.