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Pfizer Decides Not To Challenge AbbVie's Humira Biosimilar Patents

 
• By Brenda Sandburg

Pfizer is the seventh company to enter licensing agreement with AbbVie; it has completed development program for its adalimumab candidate.

Adalimumab monoclonal antibody drug. Anti-inflammatory TNF-alpha inhibitor used in treatment of rheumatoid arthritis, psoriasis, ulcerative colitis, etc. Generic name and stylized antibody.

Pfizer Inc. joined the line of companies that have opted to license rights to AbbVie Inc.'s Humira (adalimumab) patents rather than challenge them in court.

Under a global agreement announced Nov. 30, Pfizer's license period in the US will begin on Nov. 20, 2023. That...

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EU Biosimilar Filings, Opinions And Approvals

 
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
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Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.