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Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

 
• By Brenda Sandburg

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

Pharmacy RX_577276555_1200.jpg

States are ready for the US FDA's future approval of interchangeable biosimilars. As of June 4, 44 states and Puerto Rico had enacted laws allowing pharmacies to substitute an interchangeable biosimilar in place of the prescribed biological product.

Under the federal biosimilars statute, FDA is to determine if a biosimilar meets specific standards to be deemed interchangeable, and...

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More from Biosimilars

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?

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

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Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
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Biocon To Launch Approved Generic Liraglutide ‘Expeditiously’ In India

 
• By Urtė Fultinavičiūtė

Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”