How Biologics have changed the rules for the Pharmaceutical Industry

THE IMPACT OF THE LATEST GENERATION OF DRUGS FOR THE HEALTHCARE INDUSTRY
There’s been a lot of hype about the advent of biological medicines (biologics) since they first emerged in the 1980s. Already, they are providing real benefits for patients with long-term conditions such as rheumatoid arthritis, Crohn’s disease and psoriasis – and this is only the beginning. One of the fastest growing classes of therapeutic compounds, biologics are outpacing the growth of small-molecule drugs. By 2020, analysts expect biologics to account for more than a quarter of the entire pharmaceutical market. So what will these new therapies mean for the industry?

RESHAPING THE MODELS
Biologics have ‘completely transformed the way that patients are treated’, says Dale Hreczuk-Hirst, biopharmaceutical business development manager at RSSL, which provides services to the global biopharmaceutical, pharmaceutical and healthcare industries. In the 20th century, pharmaceutical research was focused on medicines constructed from small molecules designed to control diseases. In contrast, in the past decade research has focused on biologics, which are derived or manufactured from a living source and work by targeting specific chemicals or cells involved in the body’s immune system response.
 
Phil Kuhlman, associate principal scientist in biomolecular analysis at RSSL, explains that small molecules are ‘generally easy to produce and stable, so taking a small molecule is relatively easy to do orally’. However, biologics are larger proteins, peptides, nucleic acids, or cells, ‘so this world encompasses a much wider range of therapies’
Small molecules, says Kuhlman, are ‘promiscuous in their action – they get everywhere’. Biologics are much more specific and so generally have lower toxicity and also a higher safety profile than small molecules. However, he adds that disadvantages exist. ‘Because they are big, they generally can’t get to the same places small molecules can. And they also tend to travel more slowly [through the body] compared with small molecules.’
  
“The first real biologic to come on the market was human insulin, in 1982. During that decade, Kuhlman suggests industry giants missed a step compared with smaller rivals and start-ups as biologics emerged. ‘Big pharma cottoned on a bit slower [to the value of biologics], but caught up by purchasing small bio tech companies to bring that technology on board,’ he says.

“Warwick Smith, director-general of the British Biosimilars Association, agrees there has been a shift in the market. ‘Over the past 30 years, we’ve seen a shift from the new innovative “blockbuster” medicines – synthesised chemicals – to biological medicines. It’s a big change for the industry as a whole but patients benefit because [these treatments] are grown from living cultures, they can be designed to link to specific parts of the body, and therefore can be more specific and effective for certain conditions compared to chemicals,’ he says. However, Smith says biologics come at a price, as they are ‘more expensive than synthesised chemical treatments to produce, to research, and require greater monitoring of patients’
Another reason for the high cost is how drugs are priced, adds Kuhlman, as many are classed as advanced therapy medicinal products (ATMPs). ‘[ATMPs] are a cure for conditions, as opposed to controlling them,’ says Kuhlman. ‘From a pharma model, if you have a cure you can charge more money for it. But in the long run, curing that disease means more value for money [for the medicine]’.  

Given their cost, and the radical changes to how medication is being produced for patients, biologics could be seen as a major shake-up for the industry. However, Luigi Martini, chief scientist of the Royal Pharmaceutical Society, believes this change in approach to treatments is more akin to an evolution. Highlighting the ‘massive changes’ in medication over the past decade, he cites the example of ‘living medicines’ such as CAR-T (chimeric antigen receptor T-cell) therapies, which uses the immune system to kill cancer cells. ‘What we’re seeing here is advances in medicines, understanding genomes, understanding diseases, and the types of medicine changing and evolving and becoming more biological in nature,’ he says.

Originally published through Chemistry World.com, May 2019.

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