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.

Following the end of the United Kingdom’s Brexit transition period on 31 December 2020, the MHRA will implement a number of changes as the UK forges its new regulatory system.