Policy & Regulation

European Industry Calls For Support As It Juggles Multiple Challenges

 
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At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
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The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
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Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.


Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
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Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
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The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

Medicines For Europe Sets Out Trade Priorities

 
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As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.


Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
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As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

IGBA Asks G7 To Consider Access Issues

 
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The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 

Generics Bulletin reviews global regulatory developments across the world.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.


US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
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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?

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
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Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.


Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
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With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
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At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 

Generics Bulletin reviews global regulatory developments across the world.