Timescales and sourcing comparator biologics are the biggest challenges for biopharmas running biosimilars studies, says an expert.
Martin Lamb, Commercial Director of Biotec Services International, a company which provides clinical trials supplies to drug development companies, told BioPharma-Reporter.com both problems arise from industrial rivalry and the unique needs of biosimilars trials.
Unlike the makers of generic small molecule drugs, biosimilars developers are required to run comparator studies, trialling their candidate alongside its originator biologic. By contrast, generic non-biologics need only determine bioequivalence (the same rate of absorption of active ingredients) with a branded drug in roughly 30 volunteers.
Obtaining and distributing a rival biologic can be difficult, said Lamb, since other companies are understandably not forthcoming with the drugs themselves or with storage information.
Sourcing rival biologics
Managers of biosimilar trials can source their rival’s biologics through specialist wholesalers or services companies like Biotec.
The non-profit organisation TransCelerate was founded in the US in 2012 to help trial cooperation between pharma giants – including Abbott, AstraZeneca and GSK – with one of its goals being to help companies source already-marketed drugs for comparative clinical trials.
Nevertheless, sourcing rival biologics remains a difficult task, said Lamb, and can often require buying from several sources to try to stay unnoticed.
“Buying 500 patients’ worth of Herceptin from the UK might be difficult, but buying 100 from several countries could be a lot easier.”
Lamb said biosimilars companies “do try to go below the radar,” and buy from wholesale companies to guard anonymity.
But this can backfire. “If an innovator company finds out there’s a biosimilar trial going on they can stop giving discounts, and you end up paying full price. They can also restrict supply to the wholesaler they believe is supplying the drug.”
Once they obtain the biologic, trial managers can be hampered by a lack of data about safe storage and distribution.
“Biosimilar companies don’t have the temperature excursion data the original manufacturer has. If it says 2-8 degrees on label, the original manufacturer knows there is some leeway, and that the biologic can be stored outside this temperature for a short time.”
The timeframe for biosimilars is even tighter than for the clinical development of other types of drug, said Lamb, because of the race to market before biologics come off-patent.
“So let’s say we require a lot more flexibility with biosimilar studies. To accelerate patient recruitment, a company may add patients from six more countries during the trial.”
Biotec uses adaptable strategies for supplying companies with clinical trial materials and drugs.
The company works on “just-in-time” principles to maintain stock flexibility. For instance, it waits to label drug vials until just before sending them to trial centres.
“Let’s say the original plan was to do the trial only in the UK, we label everything in English. The client calls and says we want to go into France as well, that means supplies need to be relabelled. For that to happen in one language is a problem, but they may already be labelling up in ten languages.”
Without a “just-in-time” approach to packaging, relabeling multilingual stock can take eight weeks, said Lamb, as the speed is dictated by the slowest approving country.