Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

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 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.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

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.

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.

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.

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.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.

Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.

Lupin has claimed the first US approval for an Ingrezza generic – but must wait well over a decade before launching its version of valbenazine, after last year striking a patent litigation settlement with originator Neurocrine Biosciences.

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

After getting off to a slow start last year, US biosimilar rivals to Humira are beginning to gain more traction. Sandoz is increasing its share on a weekly basis, Alvotech and Teva have struck a deal for their newly-approved interchangeable 100mg/ml biosimilar, and the latest market data shows biosimilars capturing twice as much of the market in Q1 as in Q4 2023.

 The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.

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.

One down, two more to go. Celltrion seals a formulary deal with one of the top three PBMs in the US for its subcutaneous infliximab product Zymfentra.

Teva has struck a $150m strategic development funding agreement with Abingworth and a clinical collaboration agreement with Launch Therapeutics to accelerate development of a dual-action asthma rescue inhaler.

Generics Bulletin previews the most noteworthy and anticipated events for April 2024.

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

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.

After getting off to a slow start last year, US biosimilar rivals to Humira are beginning to gain more traction. Sandoz is increasing its share on a weekly basis, Alvotech and Teva have struck a deal for their newly-approved interchangeable 100mg/ml biosimilar, and the latest market data shows biosimilars capturing twice as much of the market in Q1 as in Q4 2023.

 The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.

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.

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.

A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.

Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.

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.

The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.