Policy & Regulation
Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms
Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.
Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
A few months after a positive Phase III trial readout, Henlius has filed an application for its Organon-partnered Perjeta biosimilar in its domestic Chinese market.
Generics Bulletin reviews the latest developments in the regulatory arena across the globe.
An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.
The US PTO is facing criticism after withdrawing a proposed rule that sought to address double-patenting with changes to terminal disclaimers.
Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.
The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.
The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.
Medicines for Ireland had its demands for the off-patent sector heard by some political parties, which are pledging to improve access to generic and biosimilar drugs ahead of the election.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.
In the wake of a US presidential election that saw Donald Trump returned to power, the US Association for Accessible Medicines has called for the next administration to take action to help support the generics and biosimilars market.
Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.
Despite calls to amend the Urban Wastewater Treatment Directive to protect essential and critical medicines, the EU Council gave its final approval.
Two more generics manufacturers have reached agreements with 50 US attorneys general settling claims that they artificially inflated and manipulated the prices of generic drugs for nearly a decade.
Generics Bulletin reviews the latest regulatory developments across the world.