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

Interviews


Regulation


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.

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.

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 Strikes Settlement On US Binimetinib ANDA

 
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Sandoz has reached a confidential settlement agreement after being sued over half-a-dozen US patents shielding Pfizer’s Mektovi.

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.