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Interchangeable Biosimilars May Qualify For ‘Immediate Substitution’ In Medicare Part D

 
• By Cathy Kelly

Proposed policy could help promote uptake of interchangeable biosimilars to AbbVie’s blockbuster Humira. However, some PBMs and insurers are not persuaded that interchangeability is a useful distinction so may not rush to take advantage of the new flexibility.

Part D interchangeable
Immediate Substitution Not Allowed For Non-Interchangeable Biosimilars • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Beginning in 2024, Medicare Part D plans would be permitted to substitute interchangeable biosimilars as soon as they are available, without waiting for the beginning of the next benefit year, under a proposed rule released by the Centers for Medicare and Medicaid Services on 14 December.

The policy is included in the Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program and Medicare...

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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

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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.

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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.