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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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Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
• By Dave Wallace

Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.

Big In Japan: Samsung Bioepis Looks To Increase Presence With Nipro Partnership

 
• By Dean Rudge

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Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

 
• By Urtė Fultinavičiūtė

The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

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US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

AstraZeneca Agrees Last-Minute $50m Settlement In Seroquel XR Delay Case

 
• By Dean Rudge

A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.

Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.