Policy & 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.
More than a dozen semaglutide generics hit the Indian market at sharp discounts post LOE for Novo Nordisk’s GLP-1 RA molecule, setting the stage for a high-octane battle in the diabetes and obesity segment. Can Novo hold steady amid the avalanche and what are KOLs looking for?
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Amid “significant uncertainty” for the off-patent industry caused by the war in Iran, the IGBA has warned that a prolonged conflict “could make solvent supply a critical concern” while escalating costs and squeezed margins could affect the long-term sustainability of affordable medicines.
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.
A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.
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?
With concerns building over the potential impact on medicines supply of the war in Iran, Medicines for Europe and Medicines UK have offered a measured assessment of current supply-chain pressures and the potential for future disruption.
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.