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Amgen Sued On US Stelara Biosimilar After Providing May 2023 Intent

With Janssen’s Stelara set to lose its exclusivity in September 2023, the originator is looking to ward off potential biosimilar competition from Amgen by suing the firm for patent infringement in a US district court.

Biosimilars Legal Issues

Interviews

Interviews

Accord Unveils New Ventures After A Year Of Change

A year after taking up the lead for Accord in the EMENA region, Paul Tredwell talks to Generics Bulletin in detail about the changes that he has already overseen in the role, as well as unveiling a number of new business initiatives, acquisitions and appointments that form part of his long-term growth strategy.

Strategy Leadership

Shortlist Unveiled For GGB Awards

The final shortlist of contenders has been unveiled for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt on 2 November.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

Set Alert for Commercial

Lupin Turns Up Heat With Bausch Brands Acquisition, Perforomist Generic Launch

Two acquisitions of brands in as many months, Lupin has stepped up its game in the Americas. A buyout of nine established Bausch Health brands follows rights to two from Sunovion. While it awaits news on generic(g) Spiriva, the launch of gPerforomist will help expand Lupin’s respiratory franchise

Deals Generic Drugs

Teva To Advance Digihaler Data Ecosystem With Rimdi And HealthSnap

Teva’s new partnerships will make patient data from its digital inhalers more accessible to healthcare providers, potentially placing Teva’s asthma platform at the forefront of emerging treatment paradigms.

Value-Added Medicines Deals

Faster And Cheaper: Similis Bio Aims To Enhance Biosimilar Development

In the wake of Similis Bio’s first biosimilar partnership, the JSR Life Sciences unit’s head, John Gabrielson, talks to Generics Bulletin about the Similis Bio model and how the firm believes it can help bring biosimilars to market more rapidly and efficiently.

Biosimilars Deals

Biocon Closes $3bn Deal For Viatris Biosimilars

Biocon has achieved a milestone after its Biocon Biologics subsidiary closed its $3bn deal to acquire the biosimilars business of longtime partner Viatris, in what management described as a “historic inflection point” for the Indian player.

Deals M & A

Hikma Taps Celltrion Again To Bring In MENA Stelara Biosimilar

Hikma has signed another partnership agreement to gain Middle East and North Africa commercialization rights to an ustekinumab biosimilar – although not with its US partner, Bio-Thera Solutions.

Biosimilars Deals

Advanz Zeroes In On Innovative Assets And M&A

Advanz has identified three key spaces in which it is seeking to generate value: innovative assets, M&A and existing commercial infrastructure.

Value-Added Medicines M & A
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

Brazilian Regulator Consults On Improving Rules For Registering Biosimilars

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Biosimilars Regulation

Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

Intellectual Property Generic Drugs

EPO Supports Early Unitary Patent Uptake From 1 January

The European Patent Office has adjusted the starting date of its transitional measures for applicants that want their patent to have unitary effect under the coming Unified Patent Court system.

Intellectual Property Legal Issues

Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

Generic Drugs Research & Development

Oligonucleotides, Oxycodone And Osteoarthritis Among 49 US FDA Guidances

The FDA has seemingly followed the lead of the EMA by guiding ANDA sponsors on how to develop oligonucleotide drugs, a complex class of DNA or RNA molecules.

Guidance Documents Clinical Trials

US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden

Senator Mike Lee has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct “unnecessary” switching studies in order to obtain an interchangeability designation.

Legislation Regulation
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Demand Spike Sees Sandoz, Teva Fall Short On US Amoxicillin Supply

Infants and young children across the US are continuing to struggle to get access to one of the most common and recognized antibiotics, liquid-dose amoxicillin, amid a surge in demand for the drug that has hindered generics manufacturers.

Supply Chain Generic Drugs

What’s Next? Five Things To Look Out For In December

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Biosimilars Generic Drugs

Lupin Turns Up Heat With Bausch Brands Acquisition, Perforomist Generic Launch

Two acquisitions of brands in as many months, Lupin has stepped up its game in the Americas. A buyout of nine established Bausch Health brands follows rights to two from Sunovion. While it awaits news on generic(g) Spiriva, the launch of gPerforomist will help expand Lupin’s respiratory franchise

Deals Generic Drugs
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

Amgen Sued On US Stelara Biosimilar After Providing May 2023 Intent

With Janssen’s Stelara set to lose its exclusivity in September 2023, the originator is looking to ward off potential biosimilar competition from Amgen by suing the firm for patent infringement in a US district court.

Biosimilars Legal Issues

What’s Next? Five Things To Look Out For In December

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Biosimilars Generic Drugs

Faster And Cheaper: Similis Bio Aims To Enhance Biosimilar Development

In the wake of Similis Bio’s first biosimilar partnership, the JSR Life Sciences unit’s head, John Gabrielson, talks to Generics Bulletin about the Similis Bio model and how the firm believes it can help bring biosimilars to market more rapidly and efficiently.

Biosimilars Deals
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

What’s Next? Five Things To Look Out For In December

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Biosimilars Generic Drugs

Teva To Advance Digihaler Data Ecosystem With Rimdi And HealthSnap

Teva’s new partnerships will make patient data from its digital inhalers more accessible to healthcare providers, potentially placing Teva’s asthma platform at the forefront of emerging treatment paradigms.

Value-Added Medicines Deals

Advanz Zeroes In On Innovative Assets And M&A

Advanz has identified three key spaces in which it is seeking to generate value: innovative assets, M&A and existing commercial infrastructure.

Value-Added Medicines M & A
See All
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