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Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule

 
• By Cathy Kelly

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

Biosimilar In, Reference Drug, Out
Key Takeaways

  • Part D plans can substitute interchangeable biosimilars for their reference drug on formularies immediately on approval and non-interchangeable biosimilars can be substituted after 30-days’ notice, under final rule.

Medicare Part D plans can substitute interchangeable biosimilars for their reference drugs on formularies immediately on approval and can make mid-year formulary substitutions for non-interchangeable biosimilars as long as they give beneficiaries 30-days’ notice, according to the Centers for Medicare and Medicaid Services final rule.

The rule, which covers Policy and Technical Changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program...

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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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• By Dean Rudge

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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.

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• By Dave Wallace

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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.