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.

Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

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.

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.

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.

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.

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.

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.

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.

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.

Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

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.

Pfizer has reported US oncology biosimilars sales that were down by 47% in the first quarter of 2024, as pricing pressures took their toll.

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.

Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.

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.

Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

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.

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.

Pfizer has reported US oncology biosimilars sales that were down by 47% in the first quarter of 2024, as pricing pressures took their toll.

A second tocilizumab biosimilar has been launched in the US, with Bio-Thera and Biogen together introducing their Tofidence version just weeks after Fresenius Kabi launched its first-to-market Tyenne.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch is taking place via Lupin’s local partner Sandoz.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

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 reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.