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Gottlieb unveils US biosimilars action plan

 
• By Dave Wallace

A much-anticipated biosimilars action plan (BAP) unveiled by US Food and Drug Administration (FDA) commissioner Scott Gottlieb has been warmly received by industry. Commending the release of the plan, the US Association for Accessible Medicines (AAM) called it “another key plank in the FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines”.

A much-anticipated biosimilars action plan (BAP) unveiled by US Food and Drug Administration (FDA) commissioner Scott Gottlieb has been warmly received by industry. Commending the release of the plan, the US Association for Accessible Medicines (AAM) called it “another key plank in the FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines”.

Announcing the BAP, Gottlieb outlined the plan’s four “key strategies”: improving the efficiency of the biosimilar development and approval process;...

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• By Dean Rudge

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• By Dean Rudge

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Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

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Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

More from Policy & Regulation

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.

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.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.