Outlook 2024
Annual Industry Ranking And Forecast
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Generics Bulletin reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.
Characterizing biosimilars as a global movement towards the democratization of medicine, Formycon CEO Stefan Glombitza speaks to Generics Bulletin in detail about the company’s recent deals, launches and key pipeline assets, in the first part of an exclusive two-part interview.
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.
Generics Bulletin reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.
Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
The approval brings another biosimilar to Amgen’s Neulasta, stepping up competition in an already heated market that has seen major approvals in the past year.
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.
In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.
Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
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.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
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.
With 80% of medicines used by the UK’s National Health Service being off-patent drugs, the UK is nevertheless in need of a new economic framework to save waning competition due to low prices, delegates to a Westminster Health Forum conference heard from a Sandoz executive.
Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.
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.
The FDA’s Drug Shortage Staff said it aims to resolve long-term, not just short-term, issues with drug supplies, as the country sees the highest-ever levels of drug shortages.
Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.
Sandoz has fired a defensive shot in a US court against the potential that it may have to fork up higher rebates for two of its drugs via the Centers for Medicare & Medicaid Services’ Medicaid drug rebate program – six years after the suggestion was first made.
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.
Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.
Generics Bulletin previews the most noteworthy and anticipated events for May 2024.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
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.
Generics Bulletin reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.
Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice.
In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.
The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.
Generics Bulletin previews the most noteworthy and anticipated events for May 2024.
Teva and Alvotech have confirmed deductions that it is their recently-approved 100mg/ml adalimumab biosimilar that will be used by Cigna’s Evernorth as part of a recently announced private-label deal involving Evernorth’s Quallent Pharmaceuticals.
Formycon has shared its results for 2023, reporting revenue growth and exceeding projections for its working capital, as the company prepares for approvals in the coming year.
Sandoz has secured a launch date for its newly-approved US denosumab biosimilars, settling patent litigation with Prolia/Xgeva originator Amgen.
Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.
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.
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