Policy & Regulation
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
The US FDA delivered its promise to publish product-specific guidances in November, after two late batches earlier this year. Third time might have been a charm, but it remains to be seen if the December batch will be the fourth time guaranteed.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Generics Bulletin reviews global regulatory developments across the world.
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.
Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.
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.
With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.
Despite moves made by other developers to limit biosimilar trials – as regulators around the world move towards more streamlined models – Samsung Bioepis says it is sticking with a Phase III trial program for its SB27 proposed Keytruda (pembrolizumab) rival, having just completed recruitment.
Viatris has garnered a first positive opinion from the EMA’s CHMP for a teduglutide generic rival to Revestive. At its November meeting the CHMP also endorsed further denosumab and insulin glargine biosimilars, while an insulin aspart filing was withdrawn.
Aeon Biopharma has reported positive biosimilarity and analysis data for its ABP-450 proposed rival to Botox, days ahead of a key meeting with the FDA. The company has also just agreed a pair of new financing deals to fund it well into 2026.
In the wake of recent FDA guidance on streamlining the registration pathway for biosimilars, Organon’s head of US biosimilars, Jon Martin, talks to Generics Bulletin about how the company is re-evaluating the market landscape.
Shanghai Henlius Biotech and Organon have won FDA approval for the first US biosimilar to Roche’s Perjeta (pertuzumab). Their Poherdy version has also been granted an interchangeability designation. However, launch plans may be on hold for now while the partners fight a lawsuit from the originator.
New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
Association for Accessible Medicines CEO John Murphy says the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.