DDReg Pharma

DDReg Pharma

Challenges in immunogenicity assessments for biosimilar development

The biosimilar market is rapidly growing across the globe as patents and exclusivities for biologic products approach their expiration dates. Indeed, biosimilars offer more access due to their affordability which is a key driving factor for market development, particularly in emerging markets with growing economies. However, biosimilar development is prone to many challenges, through all …

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

Regulations surrounding biosimilar development are based on how well the similarity between the proposed molecule and the reference product (RP) can be demonstrated. Indeed, there is a need for increased access to cost-effective treatment for various conditions, which drives biosimilar development. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European …

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US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA) filings, applicants should be able to demonstrate their product’s sameness or similarity to its innovator product or Reference Product (RP). All the data generated by applicants on generic versions should be equivalent or the same as that for reference listed drug (RLD). The CDER recently …

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

The pharmaceutical regulatory landscape in the UK has experienced many changes since Brexit. Several guidelines have been updated for more UK-specific pharmaceutical product regulation. Among these includes the ‘Guidance on the licensing of biosimilar products’ that was first published on the 6th of May 2021 with the aim to outline clear requirements for biosimilar product …

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An overview on some key regulatory challenges in API manufacturing

The regulatory landscape is consistently evolving as it faces ever-changing guidelines and regulations. On one hand, these patient-centric regulatory changes ensure that safe, efficacious, and high-quality pharmaceutical products reach the market. On the other hand, key stakeholders in the pharmaceutical regulatory environment face significant obstacles. Needless to say, these regulatory challenges are not limited to …

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Solutions and best practices in Publishing and submission management

The electronic transfer of regulatory information and subsequent review of drug applications is now more streamlined after decades of paper-based procedures. The electronic version of the Common Technical Document (CTD), or the eCTD, is now becoming more and more common in life sciences contexts worldwide, particularly in the regulatory landscape. Therefore, organizations must get ready …

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Challenges in eCTD Publishing & Submission Management

Electronic regulatory submissions have their roots in the late 1980s and have significantly developed over the last few years, especially in key markets. The migration from paper-based submissions to electronic submissions has revolutionized the management and exchange of regulatory information. Additionally, it enables more efficient review processes and enhances the lifecycle management of submissions. In …

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

Arthritis is an inflammatory condition that affects people worldwide leading to disabilities and decreasing the quality of life. Rheumatoid Arthritis (RA) is the most prevalent inflammatory arthritis that has triggered a revolution of treatment options over the last few decades. Though there is currently no cure for the condition, treatment regimens focus on alleviating symptoms, …

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European Medicines Agency: Biosimilar medicines can be interchanged

A biosimilar medicine is one that demonstrates high similarity to another biological medicinal product that has already been approved- this is also known as the ‘reference product’. Interchangeability refers to using one medicinal product instead of another provided the therapeutic intent is the same. In this context, interchangeability is the medicinal product being substituted by …

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Overview on Cardiovascular Medical Device Regulation by the FDA

According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important …

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