Experts state pharmaceutical regulation will shift due to increased data dependence, warn regulatory oversight is slowing six sigma adoption and forecast increased generic options 2025 onwards
CPhI Worldwide — organised by UBM — announces the findings of final section (part iii) of the fifth edition of the CPhI Annual Report, which focuses on the immediate and long-term trends in pharmaceutical data, regulation, generics and biosimilars.
The full report, published live from CPhI Worldwide in Frankfurt, used 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 inv 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, discusses how the intense battle between innovators and biogeneric companies is likely to play out in 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 states that innovators are 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. He explains: “The innovator companies will face increasing pressure to ensure access to medicines at affordable prices. But now the regulators and the governments will take on the innovators and force them to facilitate development of biogeneric versions in the next 2-3 years.”
FDA Commissioner’s recent statement will encourage biogeneric companies to be more aggressive than they have been so far. The FTC has already conveyed that it is contemplating launching a formal investigation. Thus, both drug regulator and the competition authorities will be on the same side.
Alan Sheppard, Principal of Global Generics at IMS Health, suggests in his article that there are 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.”
Sheppard emphasises that it is even not too late for pharma companies that have yet to get involved in the biosimilar market: “As with small chemical molecules there now exists biosimilar developers who are seeking partners for marketing and distribution and contract manufacturing organisations with biosimilar capabilities. If that is not an option then portfolio growth from small chemical molecules will still offer opportunities.”
“The recent increase in launches of small chemical products forecasted to be potential blockbuster molecules will offer significant generic opportunities in the years beyond 2025.”
Bikash Chatterjee, President and Chief Science Officer of Pharmatech Associates, argues 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 twenty-first 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.
As a consequence of new high-throughput technology, notably next generation sequencing, Chatterjee says that the role of data in illustrating performance and compliance will continue to increase over the next decade. Improvements in big data analytics will be crucial in highlighting the most suitable candidate drugs more quickly from e-clinical, lifestyle diagnostics and digital health initiatives.
However, Chatterjee highlighted cyber security as a potential risk factor, especially as the industry increases dependence on patient data for drug development. He added, “The industry’s ability to manage the constantly evolving threats to data management and integrity will define how we develop new drug therapies in the future.”
Ajaz S Hussain, PhD, Founder of Insight, Advice & Solutions LLC, explores 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 twenty-first century initiative — remains. Utilising 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 stresses that much of the sector is held at a development stage — 'socialised 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.
Chris Kilbee, Group Director, Pharma Portfolio at UBM EMEA: “Now in its fifth year, the CPhI Annual Report delivers detailed perspectives on the most advanced pharmaceutical practices, analyses and future predictions. CPhI Worldwide is pharma’s one true global event, with a reputation as the place to do business and learn the developments of tomorrow. This report, like the event, provides insight on all parts of the pharmaceutical supply chain.
“In part iii, experts identified exciting developments in high-throughput sequencing, potential new methods to achieve regulatory excellence and changing dynamics across the biosimilars marketplace. I would encourage all of our attendees at CPhI Worldwide and the wider industry to study the report’s full findings closely.”
For a copy of the full articles in the CPhI Annual Report 2017 — released at CPhI Worldwide in Frankfurt (24–26 October 2017) — please visit www.cphi.com/europe/cphi-annual-report