Market Access
As the US biosimilars market approaches the end of its first decade, it has seen another busy year, with Amgen’s surprise launch of a rival to Eylea shaking up expectations as other first-time approvals rolled in throughout 2024. Meanwhile, competition to Stelara is waiting in the wings from the start of 2025.
The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
As the pharmaceutical industry readies itself to navigate the complexities of 2025, US pricing trends reveal a landscape shaped by regulatory and legislative changes, innovative pricing models, and the ongoing impact of inflation.
As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.
The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.
European cross-border HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, say Nordic health technology assessment experts. Talks on HTA collaborations outside Europe are also underway.
It is time for companies to take part in cross-country health technology assessments and stop only asking “what’s in it for me?”
Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.
Germany’s Medical Research Act clears its final legal hurdle after federal council sign off.
Policy experts and consultants recount their experiences shepherding manufacturers through the first round of Medicare price negotiations during a recent webinar.
Charles Cooper, CMO of the diagnostics firm bioMérieux, talks to In Vivo about the vital nature of partnerships to fight the global AMR crisis.
China gets more complicated as multinational drug makers venture deep into it. Even with a local savvy business partner, Merck is learning to navigate through fast-shifting market dynamics amid policy changes, consumer perceptions of foreign brands, and competition from local firms as it takes stock of its market access, pricing and life cycle management strategies.
BMS has launched a new cancer drug access program for low-to-middle income countries, focusing on addressing health inequities and widening accessibility.
A public interest group has accused the pharma major of using excessive pricing to bolster sales of blockbuster Humira, consequently damaging the health of Dutch patients.
New rules on health technology assessments in Spain make room for real-world evidence and early dialog.
Texas comes out on top for biosimilar uptake, but how do the other US states compare? Geographical data can pinpoint which states are embracing biosimilars, and which have a way to go.
After years of heavy price and cost pressures that have taken a toll on firms operating in the US generics market, more recent quarters appear to have reflected a calmer and more predictable landscape.
As the US struggles to contain the cost of prescription medicines, a growing number of state governments are trying to take matters into their own hands and believe prescription drug affordability boards could be the answer.
Boston Consulting Group and senior pharma industry executives take a broad look at the challenges and opportunities for medical affairs evidence generation with multiple modalities.