Interviews
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.
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.
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.
Teva’s R&D chief Eric Hughes discusses the company’s long-acting injectable olanzapine program, how it could address adherence challenges in schizophrenia, and why the therapy forms a key pillar of the firm’s growing injectables franchise.
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.
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.
‘This Requires More Than Isolated Policy Interventions’ – Centrient Urges EU To Bolster Supply Chain
Centrient has urged the EU to strengthen its supply chain resilience, including incentivizing local manufacturing through revised procurement practices, after India took action to protect its antibiotics market from an increasing Chinese monopoly.
As the US biosimilars market sees long-desired changes in areas such as regulatory streamlining and interchangeability, Julie Reed – executive director of the Biosimilars Forum – says there are still aspects that need to evolve.
As India implements minimum import prices for certain antibiotics and key starting materials, Sandoz's Simon Goeller speaks to Generics Bulletin about the potential for Chinese suppliers to dominate the world market and weaponize supply.
After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.
‘These Decisions Created A Lot Of Uncertainty’ – Why The Supreme Court’s Skinny-Label Ruling Matters
The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.
‘It’s A Great Opportunity But It’s Also Late’ – Samsung Bioepis’ Woollett On Biosimilar Streamlining
Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.
Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.
Speaking exclusively to Generics Bulletin, Alvotech’s founder Robert Wessman explains why the company’s leadership split and Lisa Graver’s Iceland-based appointment as CEO mark a pivotal moment in its operational evolution.
After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
Axplora made waves with a recent announcement that the API specialist’s total investments for 2025 would exceed €100m. Anant Barbadikar, co-president of the firm’s PharmaZell business unit, explains how the firm’s strategy is evolving and why he believes the future of pharma remains small-molecule.
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.
In an exclusive interview with Generics Bulletin, Celltrion USA executives Tom Nusbickel and Juby Jacob-Nara discuss recent biosimilar launches, streamlining, moves into more innovative areas, and how Celltrion’s recent commitment to US manufacturing shows that the firm is “in it for the long run.”