CPhI Worldwide final section of the 5th edition of the CPhI Annual Report focuses on the immediate and long-term trends in pharmaceutical data, regulation, generics and biosimilars.
The full report was published live from CPhI Worldwide in Frankfurt amongst more than 42,000 executives, with four experts in data, regulation, generics and biosimilars – Dilip G Shah, Alan Sheppard, Bikash Chatterjee, and Ajaz S Hussain – giving their views on near- and long- term trends across the industry.
The overall findings warn that the FDA’s approach to achieving six sigma is currently failing, encouraging regulatory oversight, rather than the self-adoption of continuous quality systems by industry. A positive impact, however, was identified in the regulatory approach to data standards and analysis, which will see drug discovery and patient treatment revolutionised over the next decade. For example, investments in handling big data will allow the industry to mine lost nuggets of insight into historical performance, whilst also enabling insight from e-clinical and post-market vigilance initiatives more effectively.
The report also noted that, despite what one expert describes as the ‘abusive’ and ‘unethical’ antics of innovator companies, the development of biogenerics is continuing apace. Furthermore, with the anticipated harmonisation of biosimilar regulatory guidelines – a common dossier for use both in the US and Europe is currently under discussion – and an overall increase in players in the market, the dynamics of the biosimilar market are shifting towards congruence with the generics and adoption should now accelerate.
Dilip G Shah, CEO of Vision Consulting Group, discussed how the intense battle between innovators and biogeneric companies is likely to play out over the next three years, explaining the tide is now gradually turning in favour of generic companies thanks to pressure from patients on governments to act. Shah stated that innovators were known to impede the progress of biogeneric companies in generic and biosimilar production through morally dubious practices, yet he does not believe these methods will be fruitful in slowing down the progress of biogenerics.
Alan Sheppard, Principal of Global Generics at IMS Health, suggested in his article that there were still good opportunities for biosimilars in the industry. In the past, he claims, biosimilars were often viewed as a “risky venture” for pharmaceutical companies, but now could be the ideal time to invest. He added, “uptake of the latest biosimilars in Europe is extremely positive and is starting to track the dynamics of small molecule products.”
Bikash Chatterjee, president and chief science officer of Pharmatech Associates, argued that the emergence of a global marketplace with shared regulatory compliance is one of many factors driving change in pharmaceutical regulation. A key element to this is the adoption of the PIC/S by 50 regulatory entities (with a further 70 expected to join by 2020). There have also been important legislation changes, for example the 21st Century Cures Act in late 2016 authorised new drug and device manufacturers to utilise real-life data to establish drug safety and efficacy for FDA approval.
Ajaz S Hussain, PhD, Founder of Insight, Advice & Solutions LLC, explored why a perpetual gap between what we know and what we can practice and implement – more than a decade after the launch of FDA’s 21st century initiative – remains. Utilizing the constructive development theory of adult human development, he explores how Amgen (as a case study) reached six sigma with an error rate of just 3.4 defects per million opportunities.
Ajaz stressed that much of the sector is held at a development stage – “socialized mind”. Systems orientation begins at the “self-authored” stage of development. The Amgen case illustrates how this can be achieved. However, in the synthetic drug product sector, the legacy practices – such as the use of compendial test methods for batch release testing – and the inherent uncertainty in measurement systems for physical attributes, such as dissolution tests, can serve as a “self-imposed” 2-3 sigma barrier. This barrier contributes to high OOS rates and high rates of invalidated OOS, which is a metric that the FDA is currently seeking from industry. Often this is not appreciated, and it serves as a blind spot.