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Challenges in immunogenicity assessments for biosimilar development

Challenges in immunogenicity assessments for biosimilar development

The biosimilar market is rapidly growing across the globe as…

Differences in the regulatory pathways for biosimilar development: EU vs USA

Differences in the regulatory pathways for biosimilar development: EU vs USA

Regulations surrounding biosimilar development are based on how well the…

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA)…

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

The pharmaceutical regulatory landscape in the UK has experienced many…

An overview on some key regulatory challenges in API manufacturing

An overview on some key regulatory challenges in API manufacturing

The regulatory landscape is consistently evolving as it faces ever-changing…

Solutions and best practices in Publishing and submission management

Solutions and best practices in Publishing and submission management

The electronic transfer of regulatory information and subsequent review of…

Challenges in eCTD Publishing & Submission Management

Challenges in eCTD Publishing & Submission Management

Electronic regulatory submissions have their roots in the late 1980s…

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective

Arthritis is an inflammatory condition that affects people worldwide leading…

European Medicines Agency: Biosimilar medicines can be interchanged

European Medicines Agency: Biosimilar medicines can be interchanged

A biosimilar medicine is one that demonstrates high similarity to…

Overview on Cardiovascular Medical Device Regulation by the FDA

Overview on Cardiovascular Medical Device Regulation by the FDA

According to the World Health Organization (WHO), cardiovascular diseases (CVD)…

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