The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.
Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.
At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.
Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.
Generics Bulletin reviews global regulatory developments across the world.
A new life sciences strategy unveiled by the UK government has won plaudits from the off-patent industry for its inclusion of measures specifically geared towards generics and biosimilars – especially a £1bn savings target linked to biosimilar uptake.
Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.
In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.
In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.
Two leading German generics and biosimilars giants were the big movers in our top ten ranking of off-patent industry leaders for 2025. We reveal the latest developments among the top players in the first instalment of this year’s Generics Bulletin Top 50.
Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.
Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.
Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.
Viatris’ Mylan has won a key patent case against Novo Nordisk over generic Wegovy, with a US federal district judge ruling Mylan’s label did not encourage use that infringed Novo’s method-of-treatment patent.
