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Generics Explore this Topic
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Dr Reddy’s Enters US With Second Oracea Generic
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.
ViiV Healthcare And Medicines Patent Pool Celebrate 10-Year HIV Collaboration
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.
Sandoz ‘Surfs The Biosimilars Wave’ Despite US Natalizumab Delay
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.
Supply Chain Derisking: The Case For US-India Partnering Amid China Clout
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.
Biosimilars Explore this Topic
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Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.
Sandoz ‘Surfs The Biosimilars Wave’ Despite US Natalizumab Delay
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.
Henlius Reports Revenue Rise For First Quarter Of 2024
The Chinese biotech reported increased growth in its revenue fuelled by its portfolio of biologic drugs and biosimilars, with further plans for approvals around the world.
Boehringer Secures FDA Approval For High-Concentration Cyltezo – But Without Interchangeability
Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.
Value-Added Medicines Explore this Topic
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Podcast: The Global Generics & Biosimilars Awards 2024
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.
What’s Next? Five Things To Look Out For In May
Generics Bulletin previews the most noteworthy and anticipated events for May 2024.
Amneal Launches Ready-To-Use Pemetrexed And OTC Naloxone
Amneal launched two highly anticipated products, a ready-to-use pemetrexed injectable Pemrydi and over-the-counter naloxone spray, strengthening the firm’s focus on injectables and inhalation.
Adalvo Hails First European Launch Of Prolonged-Release Pregabalin
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.
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