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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

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FDA Approves Meloxicam Injection For Moderate-to-Severe Pain in Adults

Pharmacy Times

December 21, 2004. Related Videos Related Content Advertisement June 10th 2025 Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems Aislinn Antrim, Managing Editor June 3rd 2025 S2. Seminars in Arthritis and Rheumatism. Subscribe Now!

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ICH Q6(R1): test criteria and specifications

European Pharmaceutical Review

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/167068/2004. [Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. ICH Q8(R2) Pharmaceutical Development – Scientific Guideline. 22 June 2017. 3 February 2023.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog: Biosimilars

Of note, the 2004 accelerated approval of natalizumab (Tysabri) for relapsing-remitting multiple sclerosis was based on the Kurtzke Expanded Disability Status Scale (EDSS) score at one-year; two-year EDSS data were used to verify and describe the clinical benefit for conversion to traditional approval.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

A biosimilar is a biological medicine ‘similar’ to another biological medicine already approved in the EU (the ‘reference medicine’). 1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).