Generics

Dr Reddy’s has launched the second US rival to Oracea, shortly after Lupin introduced the first generic doxycycline 40mg capsules following a favorable district court ruling.

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.

With Sandoz delivering first-quarter growth thanks to its booming biosimilars business – and despite flat sales of small-molecule generics that suffered from a downturn in North America – the company is “well on track to surf the biosimilars wave,” according to one analyst. However, Sandoz did report a delay to progress with its natalizumab biosimilar in the US that will push back launch.

With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the space, a new study points to the pressing need for the US to address bottlenecks in the supply chain and proposes a string of approaches to partner with India in its de-risking efforts.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

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.

In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Hikma will look to guarantee US generic competition to the powerful opioid brand Nucynta, albeit in the form of an authorized generic, as questions swirl over the appetite of at least one ANDA filer to compete on an equal footing, per the terms of a patent-litigation settlement deal.

With Teva and Viatris recently under new management and Sandoz having last year split from former parent company Novartis, the three off-patent industry leaders are adopting different strategies for how they balance their generics and biosimilars interests with more innovative ventures. Generics Bulletin takes a look at the bigger picture.

India’s Biocon Limited has struck an exclusive deal for a generic version of semaglutide in Brazil with local player Biomm. And a recent court ruling means that launch could come sooner rather than later for the Ozempic rival.

With 80% of medicines used by the UK’s National Health Service being off-patent drugs, the UK is nevertheless in need of a new economic framework to save waning competition due to low prices, delegates to a Westminster Health Forum conference heard from a Sandoz executive.

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.

After the drug’s approval for use in neuropathic pain within the EU last December, Adalvo announced the analgesic’s first European launch in Germany.

The FDA’s Drug Shortage Staff said it aims to resolve long-term, not just short-term, issues with drug supplies, as the country sees the highest-ever levels of drug shortages.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.