Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.

As Samsung Bioepis seeks a US interchangeability designation for its Organon-partnered Hadlima adalimumab biosimilar, the firm’s regulatory affairs chief Byoungin Jung talks to Generics Bulletin about the significance of interchangeability for US biosimilars – and the firm’s support for legislative efforts to have all US approved biosimilars automatically designated as interchangeable.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.

Running until 5 December, the Big Give campaign run by UK-based charity International Health Partners is once again doubling the value of donations, this year to support its child oncology programs in Malawi and Cameroon.

Dr Reddy’s sees plenty of opportunity in Europe, including for the firm’s burgeoning biosimilars business. However at the same time, current European pricing policies risk exacerbating shortages and are discouraging investment, the firm’s CEO of European operations for global generics, Patrick Aghanian, tells Generics Bulletin in an exclusive interview.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.

Formycon has submitted its aflibercept candidate for European Medicines Agency consideration, following an incredibly strong Q3 which has put the company on track for a promising future.

Teva has announced a new investment from Royalty Pharma in its long-acting injectable formulation of olanzapine that is being developed for the US market with partner MedinCell.

Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels in early November. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.

At Medicines for Europe’s fifth annual value added medicines conference, the association announced that Pharmanovia CEO James Burt would take over as chair of its value added medicines sector group from Viatris executive Arun Narayan.

Now that the first license for a drug has been obtained in partnership with the program, work will begin to ensure other companies that make the product adopt the new licensed indication.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.

Running until 5 December, the Big Give campaign run by UK-based charity International Health Partners is once again doubling the value of donations, this year to support its child oncology programs in Malawi and Cameroon.

Formycon has submitted its aflibercept candidate for European Medicines Agency consideration, following an incredibly strong Q3 which has put the company on track for a promising future.

Italy’s Olon has opened its new R&D hub in Milan, shortly after announcing plans to expand a key manufacturing facility in India.

Swedish biosimilars developer Xbrane Biopharma has revealed that it is dropping development of its planned Xtrudane pembrolizumab biosimilar to Keytruda, as part of a move towards a more “focused development portfolio.” At the same time, the firm has announced job cuts as part of a new cost-savings scheme designed to help the firm “achieve a positive cash flow as soon as possible.”

Dr Reddy’s sees plenty of opportunity in Europe, including for the firm’s burgeoning biosimilars business. However at the same time, current European pricing policies risk exacerbating shortages and are discouraging investment, the firm’s CEO of European operations for global generics, Patrick Aghanian, tells Generics Bulletin in an exclusive interview.

Office of Inspector General analysis could add momentum to reforms of the rebating system.

ANDA sponsors targeting Neurocrine Biosciences’ Ingrezza (valbenazine) blockbuster are in position to launch – albeit with a 14-year wait that validates the strength of the originator’s IP.

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.