Many of today’s blockbuster drugs are delivered via injection, which can be expensive and inconvenient, as well as posing compliance challenges. The race is on to develop an oral delivery method for biologics, eliminating the need for injections. Abi Millar looks at research groups trying to solve this challenge and others.
Over the past few decades, the rise of biologics has been nothing short of meteoric. Between 2010 and 2017, around a quarter of the new molecular entities approved by the US Food and Drug Administration (FDA) fell into this bracket (63 out of a total of 262). That may not sound like a lot, but since biologics are much more expensive than small molecule drugs, they account for most of the world’s top-selling drugs by revenues. They also represent one of the fastest growing categories in pharma.
Unfortunately, biologics have a major downside when it comes to delivery. Unlike small molecule drugs, which can generally be taken orally, biologics are large, complex entities that degrade rapidly in the gastrointestinal tract. Weighing between 200 and 1,000 times the size of a small molecule drug, they almost always need to be delivered via injection or infusion. This is far less convenient than swallowing a pill, not to mention far more costly.
To take diabetes management as an example, most people with diabetes still rely on multiple daily injections. Inhalable insulin has been tried out (as per Exubera in 2006 and Afrezza in 2014) but both suffered with safety concerns and poor sales volume. Oral insulin – the holy grail of diabetes treatment – has yet to hit the market.
Read the rest of this article in the July 2020 edition of Pharma Technology Focus
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