As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

Viatris has revealed the early stages of a battle plan after it was knocked back on US FDA approval for its proposed once-monthly glatiramer acetate ‘GA Depot’ product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis.

Boehringer Ingelheim has revealed that it will supply its 50mg/ml adalimumab biosimilar to Quallent Pharmaceuticals in the US, under a recently-announced initiative that also involves Teva and Alvotech’s 100mg/ml Humira rival.

In what has been described by some analysts as a “solid start” to 2024, Organon has reported a 46% increase in revenue from its biosimilars portfolio amid broader improvement.

Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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

As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

Viatris has revealed the early stages of a battle plan after it was knocked back on US FDA approval for its proposed once-monthly glatiramer acetate ‘GA Depot’ product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis.

The US Court of Appeals for the Second Circuit has backed up a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

Biocon Limited has struck a “semi-exclusive” distribution and supply deal with Mexican player Medix for local rights to the Indian firm’s liraglutide generic rival to Saxenda.

As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

Viatris has revealed the early stages of a battle plan after it was knocked back on US FDA approval for its proposed once-monthly glatiramer acetate ‘GA Depot’ product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis.

The US Court of Appeals for the Second Circuit has backed up a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

Biocon Limited has struck a “semi-exclusive” distribution and supply deal with Mexican player Medix for local rights to the Indian firm’s liraglutide generic rival to Saxenda.

Celebrating positive trial results for its long-acting injectable olanzapine, at the same time as reporting across-the-board growth for its generics business in Q1, Teva says it is pushing forward with its “pivot to growth” strategy almost a year after it was introduced by CEO Richard Francis.

While Lupin is “truly excited with the potential” ahead, the uncertainty around upcoming product launches paints a different financial picture.

Waverley Pharma has blamed deep discounting and heavy competition for its decision to step back from generics and focus entirely on novel drug development.

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.

As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

Boehringer Ingelheim has revealed that it will supply its 50mg/ml adalimumab biosimilar to Quallent Pharmaceuticals in the US, under a recently-announced initiative that also involves Teva and Alvotech’s 100mg/ml Humira rival.

In what has been described by some analysts as a “solid start” to 2024, Organon has reported a 46% increase in revenue from its biosimilars portfolio amid broader improvement.

Teva is ramping up its activities in US biosimilars, with the launch of its Alvotech-partnered Humira rival imminent and a Stelara biosimilar slated for launch in February 2025. Tom Rainey, the firm’s senior vice president of US market access, talks about the opportunities on the horizon and how the firm is balancing its partnership model with in-house development.

Viatris has revealed the early stages of a battle plan after it was knocked back on US FDA approval for its proposed once-monthly glatiramer acetate ‘GA Depot’ product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis.

Celebrating positive trial results for its long-acting injectable olanzapine, at the same time as reporting across-the-board growth for its generics business in Q1, Teva says it is pushing forward with its “pivot to growth” strategy almost a year after it was introduced by CEO Richard Francis.

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.

As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

Viatris has revealed the early stages of a battle plan after it was knocked back on US FDA approval for its proposed once-monthly glatiramer acetate ‘GA Depot’ product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis.

Boehringer Ingelheim has revealed that it will supply its 50mg/ml adalimumab biosimilar to Quallent Pharmaceuticals in the US, under a recently-announced initiative that also involves Teva and Alvotech’s 100mg/ml Humira rival.

In what has been described by some analysts as a “solid start” to 2024, Organon has reported a 46% increase in revenue from its biosimilars portfolio amid broader improvement.

Teva is ramping up its activities in US biosimilars, with the launch of its Alvotech-partnered Humira rival imminent and a Stelara biosimilar slated for launch in February 2025. Tom Rainey, the firm’s senior vice president of US market access, talks about the opportunities on the horizon and how the firm is balancing its partnership model with in-house development.

Despite receiving mixed opinions on the Medicare Part D final rule, CMS sees support from the off-patent group AAM, which said that the new policy will have an “immediate impact” on cost reduction and increased access to biosimilars.

Coherus BioSciences feels its bearing and clout in the US pegfilgrastim market will stand it in good stead as other players scrabble to compete on the more lucrative formulations of Amgen’s Neulasta.

The US Court of Appeals for the Second Circuit has backed up a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

As well as focusing on near-term US biosimilar launches like its Alvotech-partnered US adalimumab and ustekinumab rivals to Humira and Stelara, Teva has outlined plans to launch a total of six biosimilars by 2027, with plenty more in the firm’s pipeline.

Biocon Limited has struck a “semi-exclusive” distribution and supply deal with Mexican player Medix for local rights to the Indian firm’s liraglutide generic rival to Saxenda.

Celebrating positive trial results for its long-acting injectable olanzapine, at the same time as reporting across-the-board growth for its generics business in Q1, Teva says it is pushing forward with its “pivot to growth” strategy almost a year after it was introduced by CEO Richard Francis.

Xbrane Biopharma’s recent CRL for its proposed US biosimilar to Lucentis has not prevented the Swedish company from announcing a successor to Bausch + Lomb to partner on the biosimilar’s US marketing and commercialization.