Spain’s mAbxience has named a new CEO following the departure of former chief Emanuelle Lepine. Meanwhile, Biosimilars Canada has re-elected its chair and vice-chair, while Lupin has added a pair of independent directors to its board.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

The US Federal Trade Commission is not resting on its laurels after seeing some success in its initial challenge to what it deems improper or irrelevant US patents that may be strangling cheaper generic competition.

Teva is putting its Japanese generics business up for sale, in an exit from the country’s generics market that has led the Israeli firm to register a substantial impairment charge in Q1.

Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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.

Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.

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.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

Teva is putting its Japanese generics business up for sale, in an exit from the country’s generics market that has led the Israeli firm to register a substantial impairment charge in Q1.

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.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

Teva is putting its Japanese generics business up for sale, in an exit from the country’s generics market that has led the Israeli firm to register a substantial impairment charge in Q1.

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.

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.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

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.

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.

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.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

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

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.

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.

Spain’s mAbxience has named a new CEO following the departure of former chief Emanuelle Lepine. Meanwhile, Biosimilars Canada has re-elected its chair and vice-chair, while Lupin has added a pair of independent directors to its board.

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

The US Federal Trade Commission is not resting on its laurels after seeing some success in its initial challenge to what it deems improper or irrelevant US patents that may be strangling cheaper generic competition.

Teva is putting its Japanese generics business up for sale, in an exit from the country’s generics market that has led the Israeli firm to register a substantial impairment charge in Q1.

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.

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.

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.

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.

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.

Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.

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.