European Pharmaceutical Review

JUNE 19, 2025

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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Biosimilars Packaging Documentation Drug Development 97

FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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Documentation Labelling Drug Development 144

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Drug Development Communication Labelling 65

Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Drug Pricing Packaging Labelling 130

European Pharmaceutical Review

JULY 4, 2024

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. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].

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Drug Development Documentation Labelling Biosimilars 103

Express Pharma

JULY 3, 2023

How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?

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Biosimilars Drug Development Generic Medicine Immunization 95

PharmaTech

JUNE 6, 2025

Image source: ©huiying - stock.adobe.com Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1).

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Dosage Drug Development Documentation Biosimilars 52