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

Interviews


Regulation


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.

AAM Hits Out At ‘Flawed’ Medicare Price Negotiation List

 
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Responding to the announcement by the US Centers for Medicare & Medicaid Services of the 15 additional drugs that will soon be subject to price negotiation – including Ozempic, Rybelsus and Wegovy – the Association for Accessible Medicines has called out the “short-sighted government price setting scheme” for undermining generic and biosimilar competition.

Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms

 
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Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.

Incoming US FTC Chair Endorses Agency Report Challenging PBM Generic Drug Markups

 
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Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.

US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

 

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.

Year In Review: Most Impactful Regulatory Developments In 2024

 

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.

ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

 

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

Henlius Files Chinese Application For Perjeta Biosimilar

 
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A few months after a positive Phase III trial readout, Henlius has filed an application for its Organon-partnered Perjeta biosimilar in its domestic Chinese market.

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


Sandoz Settlement Suggests J&J Buyout Caplyta May Be Tough Nut To Crack

 
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Sandoz is facing a lengthy wait for its proposed generic version of the touted mega blockbuster Caplyta (lumateperone), while the market waits with anticipation to see if the product’s robust IP can hold up to challenges from an additional six ANDA filers.

MSN Hit With Temporary Pause On Entresto Generic As US Patent Runs Its Course

 
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A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.

Romanian Raids On Boehringer Result In Eight-Figure Fine For COPD Market Abuse

 
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Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.

Will MSN Push On With US Generic Entresto Launch By The Week’s End?

 
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Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto’s US patents.