The Japanese generics giant shared its annual results for 2023 in what was a transformative year for the company that included the sale of a subsidiary and government inspections.

While investigating the potential of the Japanese market for its denosumab, Gedeon Richter is preparing for several regulatory filings, including its tocilizumab biosimilar.

Teva and Alvotech have finally launched their adalimumab biosimilar, Simlandi, in the US. While arriving many months behind their rivals, the partners are hoping that the product’s unique combination of a citrate-free, 100mg/ml high concentration and an interchangeability designation will position it for success.

Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.

Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.

Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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 Japanese generics giant shared its annual results for 2023 in what was a transformative year for the company that included the sale of a subsidiary and government inspections.

With UK shortages and price rises making headlines in early 2024, April’s generic pricing data suggested an easing of pricing increases, according to the latest figures from WaveData.

Cipla is stepping into the oligonucleotides space, where it also hopes to help shape the regulatory environment. Action is also anticipated in ‘big, identified areas’ such as obesity that may see potential partnering opportunities with Eli Lilly, with which the Indian firm has an existing alliance for diabetes therapies.

Four years after entering a guilty plea in response to US generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside of a jail cell and pay a token criminal fine.

The Japanese generics giant shared its annual results for 2023 in what was a transformative year for the company that included the sale of a subsidiary and government inspections.

With UK shortages and price rises making headlines in early 2024, April’s generic pricing data suggested an easing of pricing increases, according to the latest figures from WaveData.

Cipla is stepping into the oligonucleotides space, where it also hopes to help shape the regulatory environment. Action is also anticipated in ‘big, identified areas’ such as obesity that may see potential partnering opportunities with Eli Lilly, with which the Indian firm has an existing alliance for diabetes therapies.

Four years after entering a guilty plea in response to US generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside of a jail cell and pay a token criminal fine.

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.

While investigating the potential of the Japanese market for its denosumab, Gedeon Richter is preparing for several regulatory filings, including its tocilizumab biosimilar.

Teva and Alvotech have finally launched their adalimumab biosimilar, Simlandi, in the US. While arriving many months behind their rivals, the partners are hoping that the product’s unique combination of a citrate-free, 100mg/ml high concentration and an interchangeability designation will position it for success.

Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.

Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.

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.

The Japanese generics giant shared its annual results for 2023 in what was a transformative year for the company that included the sale of a subsidiary and government inspections.

While investigating the potential of the Japanese market for its denosumab, Gedeon Richter is preparing for several regulatory filings, including its tocilizumab biosimilar.

Teva and Alvotech have finally launched their adalimumab biosimilar, Simlandi, in the US. While arriving many months behind their rivals, the partners are hoping that the product’s unique combination of a citrate-free, 100mg/ml high concentration and an interchangeability designation will position it for success.

Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.

With UK shortages and price rises making headlines in early 2024, April’s generic pricing data suggested an easing of pricing increases, according to the latest figures from WaveData.

Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.

Cipla is stepping into the oligonucleotides space, where it also hopes to help shape the regulatory environment. Action is also anticipated in ‘big, identified areas’ such as obesity that may see potential partnering opportunities with Eli Lilly, with which the Indian firm has an existing alliance for diabetes therapies.

With an already established network, Formycon’s aflibercept biosimilar licensee Klinge follows in the same footsteps by picking MS Pharma as its MENA region partner.

Four years after entering a guilty plea in response to US generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside of a jail cell and pay a token criminal fine.

Dr Reddy’s shapes journey to the top 5 league on home turf, backed by a string of deals with big pharma to bridge portfolio gaps and supplement its base business. Can they deliver impactful gains in the competitive Indian market?

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.