Generics Bulletin - News And Expert Analysis On Generics And Biosimilars since 2003

Interviews


Is Teva-Amneal Inhaler Case A Double-Edged Sword For The Generics Industry?

The Teva v. Amneal battle over inhaler patents in the FDA’s Orange Book has become a noteworthy case that will impact both branded and generic drug companies. Yet, the clarity over patent listings might be overshadowed by possible future litigations, discussed law firm Polsinelli’s chair Chad Landmon with Generics Bulletin.

Regulation


Trump And Tariffs Top AAM’s Access! Agenda

 
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At a lively AAM Access! conference in Florida this week, the latest actions taken by Donald Trump ranked high on the agenda. But as well as acknowledging the negative effects of potential tariffs, the AAM’s president and CEO John Murphy also suggested that the advent of the second Trump administration could offer an opportunity for the generics and biosimilars sector to make its voice heard on proposed market reforms.

Trump’s Tariffs Would Make Generic Drug Sales Value ‘Much Worse,’ Cautions AAM

 

The Association for Accessible Medicines has urged the Trump administration not to impose proposed tariffs on the off-patent drug sector to avoid drug shortages and additional costs for manufacturers.

AAM Urges CMS To Enforce Its Rightful Power Over Medicare Part D Formularies

 

While the AAM encouraged CMS to impose its “clear authority” to regulate Medicare Part D formularies, the agency announced that the Trump administration will continue the second cycle of Medicare price negotiations, which has been criticized by the US off-patent trade group.

Celltrion Considers US Manufacturing In Response To Trump Tariffs

 
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Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump.

Chinese Body Pledges Action Over Quality Concerns

 
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China’s National Healthcare Security Administration has responded to reports of complaints from Chinese healthcare professionals about the quality and efficacy of generics purchased through the country’s volume-based procurement scheme.

FDA Promises Imminent Guidance On Interchangeable Biosimilar Exclusivity

 
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The FDA’s CDER has set out a 2025 guidance agenda that promises long-awaited guidance on first interchangeable biosimilar exclusivity, as well as a host of other documents relevant to generic drug development and registration.

Regulatory Recap: EU Pharma Groups Advocate For Electronic Product Information Rollout

 

Generics Bulletin reviews global regulatory developments from late 2024 and new updates from this year.

As Trump Takes Office, RFK Jr Faces Questions Over Generics

 
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New US president Donald Trump’s pick for HHS secretary, Robert F. Kennedy Jr, has been sent a slew of questions by senator Elizabeth Warren that touch on a number of areas of relevance for generics.

Value-Added Medicines


Building A Sustainable Market: New Medicines For Europe President Sets Out Priorities

 
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Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.

‘We’re Creating A Global Presence’ – Aspargo Labs CEO On Reformulating Drugs And Smart Devices

 

In an exclusive interview with Generics Bulletin, Aspargo Labs CEO Michael Demurjian discusses the importance of reformulated liquid oral suspension drugs, while outlining plans to launch a smart device that connects patients and doctors.

Teva Plots Out 2026 Launch For ‘Night And Day’ Olanzapine Long-Acting Injectable

 
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At the J.P. Morgan Healthcare Conference in San Francisco, Teva has provided a timeline for its much-talked-about long-acting injectable olanzapine candidate, after wrapping up a Phase III clinical trial with data that the firm believes will give it a major advantage over its competitors.

Rosemont And Hyloris Agree US Tie-Up On Valacyclovir

 
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Rosemont Pharmaceuticals will commercialize Hyloris’ proprietary valacyclovir oral suspension in the US under a new partnership that has been agreed between the two firms.

Legal & IP


No SPCs In The UK For New Therapeutic Uses As Appeal Court Aligns With EU Ruling

 

While the UK Court of Appeal’s decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients.

Novartis Keeps Faith That Six-Month Entresto Extension Will ‘Be Respected’

 
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Reporting global Entresto sales of more than $7.8bn in 2024, Novartis spoke to investors on the latest legal dynamics for its best-selling product as the threat of US generic competition from MSN Laboratories continues to loom.

Lannett’s US Selexipag Chance Moved Back To 2030, Alembic Leads The Charge

 
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Lannett will recognize the validity and enforceability of pair of US patents shielding the tablet formulation of J&J’s Uptravi (selexipag) blockbuster until 2030, under a consent judgment and order of permanent injunction signed by a judge in a federal district court in Delaware.

Celltrion Settlement Puts Prolia And Xgeva Biosimilars On Ice – But Only Until June

 
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Celltrion has shaken hands with Amgen on a settlement agreement for its proposed US rivals to Prolia/Xgeva, as it continues to await approval from the US FDA for its biosimilar denosumab candidates.