Policy and Regulation
Regulation Explore this Topic
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Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.
European Progress On Biosimilars Is Just The Beginning
Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.
EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry’
The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.
FDA-EMA Advice Pilot For Complex Generics: What Does Industry Have To Say?
The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.
Pricing Strategies and Reimbursement Explore this Topic
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Biosimilars Council Calls Out PBMs For Suppressing Humira Biosimilars Adoption
The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.
Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs
The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.
Vardenafil Vaults To The Top Of UK Price Rises In March
Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.
Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule
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.
Intellectual Property Explore this Topic
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ViiV Healthcare And Medicines Patent Pool Celebrate 10-Year HIV Collaboration
On the heels of a decade-long partnership with ViiV Healthcare that has helped 24 million people with HIV, the Medicines Patent Pool introduces a new version of its patent database for essential medicines and COVID-19 vaccines.
Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.
What’s Next? Five Things To Look Out For In May
Generics Bulletin previews the most noteworthy and anticipated events for May 2024.
Vanda Comes Up Empty Handed As US Supreme Court Denies Hetlioz Appeal
Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.
Market Intelligence Explore this Topic
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Cigna Move Offers More Good News For US Humira Biosimilars
Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.
The Comeback Begins? Positive Signs Seen For Humira Biosimilars In US
After getting off to a slow start last year, US biosimilar rivals to Humira are beginning to gain more traction. Sandoz is increasing its share on a weekly basis, Alvotech and Teva have struck a deal for their newly-approved interchangeable 100mg/ml biosimilar, and the latest market data shows biosimilars capturing twice as much of the market in Q1 as in Q4 2023.
Biosimilars Council Calls Out PBMs For Suppressing Humira Biosimilars Adoption
The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.
Vardenafil Vaults To The Top Of UK Price Rises In March
Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.
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