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Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.
Navigating the Biosimilar Landscape: A deep-dive into Regulations, Challenges & Future Trends in the EU and US
The first regulation and guidance for similar biological medicinal products (‘biosimilars’) was introduced by the European Union, as it was considered impossible to make exact copies of biopharmaceuticals.
BIA/MHRA Regulatory Innovation Conference
In July 2021, MHRA published their two-year roadmap: ‘Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023; Putting patients first: A new era for our agency’, within which scientific innovation, healthcare access and patient safety were called out as top priorities.
Regulatory Aspects of Paediatric Drug Development
Paediatric drug development is a complex and challenging process, due to ethical, methodological, operational and financial limitations. Paediatrics are not a uniform sub-group and the medical needs, biological and physiological characteristics of neonates, for example, are very different to that of adolescents.
Approaches and Regulatory Considerations
Successful approval of biological medicinal products in the EU and US require characterisation of biological products’ properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market.
Biosimilar Development: Commonly asked Questions & Answers.
A biosimilar is a biological medicine that is highly similar to another biological medicine already approved. With a large number of blockbuster innovator products reaching their patent expiry dates in the next 10 years, biosimilar development continues to be a highly lucrative field.
Novel Tools for Modern Drug Development: A US Perspective.
A drug development tool (DDT) is a measurement or method (and associated materials) that aids drug development. DDTs can be used in a drug development program without it going through the qualification programs.
Early Interaction With Regulators on Innovative Technologies.
The role of regulators has expanded from not only safeguarding the quality and safety of products, but also to ensuring that guidelines evolve to consider the new generation of scientific technologies.
US FDA Expedited Review Processes: Fast Track Designation and Breakthrough Therapy Designation.
For a medicine to be approved, Sponsors need to demonstrate that it has a positive risk-benefit balance in the proposed target population, and is of satisfactory quality.
Life Sciences. Cell & Gene Therapy: Investing in a New Tomorrow?
Click to read BDO’s latest published whitepaper in collaboration with the team here at Scendea.