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US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

 
• By Derrick Gingery

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

Sign outside of FDA's headquarters in White Oak, MD
The completed BsUFA III agreement includes supplement timeline improvements

US biosimilar user fee talks have ended with confirmation that a regulatory science program will be created, resolving an issue that emerged at the start of the talks about three months prior.

The FDA agreed to an industry counterproposal to allow biosimilar regulatory science research during a 25 May meeting, according to...

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Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
• By Dave Wallace

Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
• By Dean Rudge

In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

More from Products

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
• By Dean Rudge

In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
• By Dave Wallace

As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.