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Not So Different: Has Brexit Hindered Biosimilar Development?
Maria Manley, LLM, a life sciences expert, talks about how the United Kingdom’s exit from the European Union has changed the regulatory landscape for biologics.
At the beginning of 2021, the United Kingdom officially parted ways with the European Union in the landmark event known as Brexit. Under Brexit, regulatory reforms have created challenges for pharmaceutical companies, including biosimilar developers, forcing them to restructure their activities to fit the needs of the British government’s policies and ensure that their products could still be marketed in the United Kingdom and across the European Union. The new regulatory independence in the United Kingdom has also created opportunities for innovation and growth.
We spoke with Maria Manley, LLM, a London-based partner with Sidley Austin and an expert on the life sciences, about the pros and cons of Brexit for the UK’s biologics industry.
To learn more about Brexit's impact on the biologics industry, click here.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
