Biosimilars & Generics

With the first US Humira rival having just hit the market and biosimilars seeing increasing adoption overall, Craig Burton – executive director of the AAM’s Biosimilars Council – says that the US biosimilars market is ‘doing better, but we still have improvements to make.’

With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.

Pfizer’s $43bn agreement to acquire Seagen would layer its portfolio and pipeline with vastly complex antibody-drug conjugates – a class of drug that execs feel might be almost immune to biosimilar competition. Generic firms’ history of frustration with ADCs suggests they may be right.

Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.

President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster. 

Pink Sheet reporters and editor discuss learnings from a generic drug industry trade association conference, as well as FDA Commissioner Robert Califf’s ideas for advisory committee changes and using emergency use authorizations in non-COVID-19 areas.

AAM hopes everyday voices – and Mark Cuban’s – will help policymakers appreciate the contributions that generic drugs make to the healthcare system. ‘We need to create an emotional connection,’ a campaign designer said.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Updated plans to implement pharmacy-level biosimilar substitution in Finland have been published by a parliamentary health committee ahead of expected formal approval within weeks, reflecting certain industry criticisms that have now been taken on board.

Prompted by an Executive Order on drug price competition, the cross-agency training aims to ensure that the Patent and Trademark Office is aware of all information that FDA makes available.

Vaccine makers get all the credit (among those who think any credit is due) for ending the pandemic, but generic sponsors want to remind policymakers that their plants stayed open during the worst of COVID-19 to ensure that hospitals were stocked and medicines for chronic conditions didn’t run short.

The new chair of the US generics association talks to the Pink Sheet about how to make sure that policymakers don’t take the industry for granted.