Outlook 2024
Annual Industry Ranking And Forecast
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Fresenius Kabi enjoyed a good start to 2024, boosted by the recent US launch of its biosimilar tocilizumab product and a key licensing agreement signed with Teva – factors that have allowed the German generics and biosimilars giant to boost its financial guidance for 2024.
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.
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.
Fresenius Kabi enjoyed a good start to 2024, boosted by the recent US launch of its biosimilar tocilizumab product and a key licensing agreement signed with Teva – factors that have allowed the German generics and biosimilars giant to boost its financial guidance for 2024.
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.
Spain’s mAbxience has named a new CEO following the departure of former chief Emanuelle Lepine. Meanwhile, Biosimilars Canada has re-elected its chair and vice-chair, while Lupin has added a pair of independent directors to its board.
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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.
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.
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.
With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the space, a new study points to the pressing need for the US to address bottlenecks in the supply chain and proposes a string of approaches to partner with India in its de-risking efforts.
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.
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.
Fresenius Kabi enjoyed a good start to 2024, boosted by the recent US launch of its biosimilar tocilizumab product and a key licensing agreement signed with Teva – factors that have allowed the German generics and biosimilars giant to boost its financial guidance for 2024.
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.
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.
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.
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.
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.
Fresenius Kabi enjoyed a good start to 2024, boosted by the recent US launch of its biosimilar tocilizumab product and a key licensing agreement signed with Teva – factors that have allowed the German generics and biosimilars giant to boost its financial guidance for 2024.
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.
Spain’s mAbxience has named a new CEO following the departure of former chief Emanuelle Lepine. Meanwhile, Biosimilars Canada has re-elected its chair and vice-chair, while Lupin has added a pair of independent directors to its board.
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.
The US Federal Trade Commission is not resting on its laurels after seeing some success in its initial challenge to what it deems improper or irrelevant US patents that may be strangling cheaper generic competition.
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.
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.
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.
The Chinese biotech reported increased growth in its revenue fuelled by its portfolio of biologic drugs and biosimilars, with further plans for approvals around the world.
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