Regulation
Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
The US FDA released one of the highest numbers of product-specific guidances for generic development in a single batch.
The latest biosimilars guidance from the FDA – which promises to further streamline applications by making it easier for developers to rely on non-US comparator products – has been warmly received by the off-patent industry.
In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.
As the US biosimilars market continues to evolve, Cardinal Health’s director of biosimilars Dracey Poore talks to Generics Bulletin for an exclusive Q&A.
The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.
Europe is facing one of the biggest pharmaceutical reforms in two decades. Medicines for Europe’s Beata Stepniewska and Adrian van den Hoven outlined how the regulatory trinity – EU pharmaceutical legislation, Critical Medicines Act, and Biotech Act – will reshape the industry.
As the US Supreme Court prepares to review litigation over skinny-label generics with carved-out indications, Hikma has once again won the backing of the US solicitor general for its position.
Glenmark says it plans to launch imminently the first US generic fluticasone propionate rival to Flovent, for which it has just received FDA approval – with an added bonus of 180 days of Competitive Generic Therapy exclusivity.
At the AAM’s Access! 2026 conference, a dedicated panel on the latest developments for biosimilars discussed challenges and opportunities in the US market, predicting consolidation among current players as well as calling for policies that put biosimilars first.
At its February meeting, the EMA’s CHMP issued positive opinions for six biosimilars – including the first rival to Perjeta.
As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’
In a petition filed to HHS, non-profit Public Citizen requested the current administration to use its statutory authority to allow earlier generic competition for Novo Nordisk and Eli Lilly’s GLP-1 blockbusters.
AAM president and CEO John Murphy summarized a year of progress for the off-patent industry in front of an audience of generics and biosimilars industry delegates at the AAM’s Access! 2026 annual conference – but also said more efforts were needed to create a sustainable future environment.
The idea proposed by industry could be an attempt to increase first-cycle approvals and reduce overall review times, but the FDA has questions.
Generics Bulletin reviews global regulatory developments across the world.