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.

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.

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.

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.

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.

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.

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.

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.

Click to read BDO’s latest published whitepaper in collaboration with the team here at Scendea.

Clinical trials are historically associated with extensive inclusion and exclusion criteria, to deliver results which reflect an acceptable level of validity.

A rare disease is any disease that affects a small percentage of the population, although the exact definition varies across jurisdictions. While each disease is rare, collectively, these disorders affect 6–7% of the population in the developed world.

FDA offers formal advice at no cost to developers of medicines regulated by both CDER and CBER, with the aim of supporting medicinal product development from Phase 1 through to marketing.