Many established biotechs with approved products have developed strategies to mitigate counterfeit risks but fewer emerging companies fully consider the problem. However, potential acquirers will assess this before purchase so emerging biotechs should be prepared.
This is the view that emerges in a white paper, based on interviews and a panel session at BIO 2010, from Cambridge Consultants. The white paper recommends biotechs understand the implications of counterfeit and diverted medications at a business and an individual product level.
For some respondents having this knowledge, and plans for product protection, is a requirement in an acquisition target. However, due to costs, and the likelihood a buyer will implement their own methodologies, integrating technology into the manufacturing process is unnecessary.
Instead, respondents recommended biotechs characterise product risk, consider mitigating strategies and negotiate vendor contracts to allow for future implementation of security measures.
Performing this process at an early stage will be significantly cheaper than attempting to retrofit a business process or anti-counterfeiting measures after a system is operational. Also, counterfeit ingredients and products have been found in clinical trials, highlighting the need for early action.
Biotechs should also be aware that counterfeiters may target drugs that are still in development. “Some erectile dysfunction drug counterfeits were on the market before the real product was”, says the white paper.
Threats to biologics
Discussion about counterfeiting and diversion generally focus on small molecules but biologics face some unique threats and must also be considered. For instance, data from the Pharmaceutical Security Institute indicates counterfeiting of injectables is on the rise.
In 2008 there were more than 150 incidents involving counterfeit injectables, up from around 50 in 2004. Counterfeit injectables accounted for 10 per cent of all cases of fake products being detected in the legitimate supply chain in 2008.
Furthermore, diversion poses a particular threat to biologics. Diversion is the movement of legitimate products into other more profitable markets or the illegitimate supply chain.
Incidents of diversion of biologics may move the product into a supply chain which lacks the safeguards, such as temperature control, needed to ensure treatment quality and efficacy. Consequently, diverted biologics could pose a particular threat to patients.
A layered solution
Layers of anti-counterfeiting technology covering tamper evidence, serialisation and authentication should be implemented by biotechs implementing a full strategy.
“The brand owner carries the risk of poor system performance, not the system or technology provider, and therefore being an intelligent customer is crucial”, says the white paper.
Once technology is chose and the system implemented companies must continue to monitor operations. Counterfeiters will change their tactics in response to mitigation strategies so continuous improvement is needed.