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Biosimilars

Set Alert for Biosimilars

Pfizer Calls For Sustainable Approach To Ensure Viability Of Biosimilars Market

Global biosimilars player Pfizer is calling for a more sustainable approach to the market to ensure its long-term viability. In the second part of an exclusive interview, Barry Chester, the firm’s global commercial lead for supportive care oncology, tells Generics Bulletin where the company sees room for improvement.

Biosimilars Strategy

Dr. Reddy’s Aurigene Unit Opens New Indian Biologics Facility

The Dr. Reddy subsidiary CRDMO Aurigene has opened a new biologics facility in India, with plans to finish the plant’s manufacturing capabilities later this year.

India BioPharmaceutical

Alvotech And Stada Are Back With A Denosumab Biosimilar Deal

With an ustekinumab biosimilar launch in Europe just around the corner, Alvotech and Stada have reconsidered the previously dropped denosumab partnership, while commercial rights to the aflibercept biosimilar go back to Alvotech.

Deals Strategy

‘We’ve Got The Broadest Pure-Play Oncology Portfolio In The industry’ – Pfizer Talks Biosimilars

Pfizer is one of the leading players in the global biosimilars market. Barry Chester, the firm’s global commercial lead for supportive care oncology, talks to Generics Bulletin about how the business fits into the firm’s wider interests, in the first part of an exclusive interview.

Biosimilars Strategy

Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar

Biocon has been handed a further setback in its attempts to launch a biosimilar to the market-leading Eylea in the US, after a US district court signed off on a permanent injunction against the Indian firm lasting until June 2027. Meanwhile, decisions on motions for preliminary injunctions against several other biosimilar sponsors are imminent.

Legal Issues Litigation

‘Keytruda? We Believe Opdivo Is The Better Choice’: Xbrane’s CEO Martin Åmark

The CEO of Xbrane Biopharma, a Swedish firm focused solely on biosimilar development using a partnered model to potentially take its biosimilars across the globe, speaks exclusively to Generics Bulletin about its ambitions and challenges, including the recent setback for its proposed Lucentis biosimilar in the US.

Biosimilars Strategy

Samsung, Biogen Co-Operate Amid Italian Antitrust Investigation Into Biosimilar Lucentis

Did Samsung Bioepis and Biogen choose early US access for its Lucentis biosimilar in exchange for postponing launch in other global markets? That’s what Italy’s competition authority believes, as it kicked off an investigation into both the biosimilar sponsors and originators Genentech and Novartis.

Regulation Legal Issues

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.

Strategy Generic Drugs

IGBA Celebrates ICH Re-Election And CEO Committee Progress

In a busy month for the IGBA, the global off-patent industry association has celebrated re-election to the ICH’s management committee and has held a meeting of its own CEO advisory committee.

Generic Drugs Biosimilars

FDA’s Yim Talks Biosimilars – In A Reddit AMA

In an “ask me anything” Q&A on Reddit, Sarah Yim – director of the FDA’s Office of Therapeutic Biologics and Biosimilars – offered some insights on the US biologics naming convention, biosimilar interchangeability, and the possibility of future competition on cell and gene therapies.

Biosimilars Regulation

‘Pegfilgrastim, We Are Definitely Going To Take It To The US Market,’ Says Aurobindo

While outlining key dates for its biosimilars portfolio, Aurobindo remains confident in the US market stability for its products.

Biosimilars Launches

Industry Body Calls For Action In Response To EU Initiatives

Medicines for Europe has responded to two EU initiatives linked to biosimilars and generic drugs in quick succession, calling for action in reaction to drug shortages.

BioPharmaceutical Europe

Outlook Sets Out Plans For Ophthalmic Bevacizumab In Europe

Outlook Therapeutics has revealed more details of its European launch strategy for its Lytenava ophthalmic bevacizumab following the product’s formal European Commission approval.

Approvals Launches

Biosimilars Council Urges Global Comparators And Dropping ‘Unnecessary’ Studies

In a position paper published by the AAM’s Biosimilars Council, the industry association has called for a streamlining of the FDA’s approval process for biosimilars that includes eliminating “unnecessary” clinical efficacy studies and establishing global regulatory comparators.

Biosimilars Regulation

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

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

Biosimilars Generic Drugs

Sandoz And Bio-Thera Get EU Nod For Bevacizumab

At its May meeting, the EMA’s CHMP has issued positive opinions for Sandoz and Bio-Thera’s Avzivi partnered biosimilar rival to Avastin, as well as five generics that included a trio of pomalidomide products.

Approvals Biosimilars
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