Leadership
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.
Generics Bulletin brings you the most noteworthy recent appointments in the off-patent and value-added medicines space.
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.
Sandoz has unveiled a major reorganization of its generics and biosimilars operations into two distinct businesses, bringing in Ferring and Merck veteran Armin Metzger to lead a new global biosimilars unit while at the same time assigning existing executives to generics roles.
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.
Following the departure of Hikma’s former CEO Riad Mishlawi at the end of last year, the company’s chair Said Darwazah has once again taken on the chief executive role for the next two years, amid a slew of other management changes.
‘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.
The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.
‘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.
A couple of months after leaving Hikma, former Custopharm CEO and Hikma injectables chief Bill Larkins has been named as the new president of Par Health’s injectables business.
As Denmark’s Orifarm announced the appointment of Jutta Schnirring-Mayer as chief business development and portfolio strategy officer – the latest in a line of management changes under new CEO Mads Fink Eriksen – the firm set out its ambitions to expand its European generics business.