Outlook 2024
Annual Industry Ranking And Forecast
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Following what Cardinal Health described as “a year of monumental developments in biosimilars,” the firm’s director of biosimilars, Dracey Poore, spoke to Generics Bulletin for an exclusive Q&A.
As Biocon Biologics makes multiple moves to position its recently-integrated US biosimilars business for success, the firm’s chief commercial officer for advanced markets, Matt Erick, tells Generics Bulletin that US biosimilar competition is a “marathon” that is “not going to be won in the short term.”
The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.
Following what Cardinal Health described as “a year of monumental developments in biosimilars,” the firm’s director of biosimilars, Dracey Poore, spoke to Generics Bulletin for an exclusive Q&A.
Partners Fresenius Kabi and Formycon have laid the groundwork to launch their biosimilar ustekinumab rival to Stelara in Europe and Canada through a settlement agreement with originator J&J.
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing debate over the need for interchangeability.
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also lead to earlier market entry for off-patent drugs.
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing debate over the need for interchangeability.
The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections.
Something old, but also something new for generic drugs in the latest FDA’s legislative proposal package.
The proposal is not expected to cost or save the government money, but is expected to increase biosimilar uptake, according to budget documents.
A raft of different generics saw their average UK trade price more than double in February 2024, according to the latest figures from market researcher WaveData.
An upbeat Sandoz pointed to growth across all its regions and businesses in 2023, as the firm delivered its first annual results as a standalone company.
Something old, but also something new for generic drugs in the latest FDA’s legislative proposal package.
Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance.
A raft of different generics saw their average UK trade price more than double in February 2024, according to the latest figures from market researcher WaveData.
An upbeat Sandoz pointed to growth across all its regions and businesses in 2023, as the firm delivered its first annual results as a standalone company.
Something old, but also something new for generic drugs in the latest FDA’s legislative proposal package.
Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance.
Amneal continues to see a bright future in the biosimilars business as it looks for new portfolio additions, and gets ready for several complex product launches, some even yet to be disclosed, this year.
UK competition watchdog the CMA has announced that it will be appealing against a tribunal decision that has overturned nearly £100m of fines imposed over anti-competitive deals around hydrocortisone, based on what the CMA criticized as a “fundamentally misconceived procedural point” linked to the cross-examination of witnesses.
Sandoz has a goal of increasing generic penetration in Ireland, which lags behind its European neighbors. As part of that objective, the firm has opted to take full control of its Rowex joint venture, based in County Cork.
KVK Research and KVK Tech failed to notify the US FDA about the use of a foreign API manufacturing facility and submitted alleged false claims to governmental health programs.
Powered with robotic and artificial intelligence technologies, Mark Cuban’s Cost Plus Drug Company aims to manufacture drugs in shortage and bypass pharmacy benefit managers.
UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.
Generics Bulletin reviews Viatris’ 2023 financial year, and its prospects ahead of a busy 2024.
For the fifth year in a row, more than half of generic drugs are placed on non-generic tiers on Medicare Part D plans, resulting in higher cost-sharing requirements despite the price decrease for generics.
Following what Cardinal Health described as “a year of monumental developments in biosimilars,” the firm’s director of biosimilars, Dracey Poore, spoke to Generics Bulletin for an exclusive Q&A.
Partners Fresenius Kabi and Formycon have laid the groundwork to launch their biosimilar ustekinumab rival to Stelara in Europe and Canada through a settlement agreement with originator J&J.
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing debate over the need for interchangeability.
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But could the firm get the first US biosimilar approval?
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as Remsima SC.
Viatris offered little in the way of detail as it announced a setback for its Mapi Pharma-partnered proposed once-monthly glatiramer acetate product for relapsing forms of multiple sclerosis. The firm has previously shouted from the rooftops about Mapi’s Phase III clinical study and the potential to establish a new standard of care for glatiramer acetate patients.
Generics Bulletin reviews Viatris’ 2023 financial year, and its prospects ahead of a busy 2024.
Generics Bulletin previews the most noteworthy and anticipated events for March 2024.
Following what Cardinal Health described as “a year of monumental developments in biosimilars,” the firm’s director of biosimilars, Dracey Poore, spoke to Generics Bulletin for an exclusive Q&A.
Partners Fresenius Kabi and Formycon have laid the groundwork to launch their biosimilar ustekinumab rival to Stelara in Europe and Canada through a settlement agreement with originator J&J.
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing debate over the need for interchangeability.
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also lead to earlier market entry for off-patent drugs.
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But could the firm get the first US biosimilar approval?
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as Remsima SC.
After last year’s launch in Jordan, Formycon and partner MS Pharma are now planning the second launch in the Middle East, with more to come later in 2024.
The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections.
A raft of different generics saw their average UK trade price more than double in February 2024, according to the latest figures from market researcher WaveData.
Coherus BioSciences has spoken in detail about its full suite of Udenyca pegfilgrastim biosimilar products and how it plans to return to growth and positive cash flow moving forward – although it cannot, for now, provide an estimate for 2024 revenues.
Endo’s generic and injectable segments struggled last year, with even lower projections for 2024, but potential financial restructuring may help the company rise from the ashes.
“We are extremely well aware of the consequences for investors that cannot protect their ownership share in this transaction,” Xbrane has told its investors, as the Swedish firm looks to tie up much-needed capital injection via a right issue to fuel its pipeline of biosimilar projects.
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