The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM.
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This section, which focused on the immediate and long-term trends in pharmaceutical data, regulation, generics and biosimilars, included a warning that the six sigma adoption is slowing as a result of regulatory oversight, and has forecasted an increase in generic options from 2025.
One of the experts who contributed to the report, 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.
“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 over the next 2–3 years,” he added. “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, suggested in his contribution to the report that there are still good opportunities for biosimilars in the industry. He said, “Uptake of the latest biosimilars in Europe is extremely positive and is starting to track the dynamics of small molecule products.
“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,” he continued. “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.”
Another of the experts who participated in this year’s annual report, 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. Key to this is the adoption of the PIC/S by 50 regulatory entities, he revealed, as well as other important legislation changes that have been introduced, such as the 21st Century Cures Act.
Chatterjee highlighted the increasing role of data in illustrating performance and compliance and stressed that improvements in big data analytics will be crucial in identifying the most suitable candidate drugs more quickly from e-clinical, lifestyle diagnostics and digital health initiatives. However, he also emphasized cyber-security as a potential risk factor, especially as the industry increases dependence on patient data for drug development.
“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,” he explained.
The founder of Insight, Advice & Solutions, Ajaz S. Hussain, PhD, explored why a perpetual gap between what we know and what we can practice and implement still exists. Using Amgen as a case study, he looks at how the company reached six sigma with an error rate of 3.4 defects per million opportunities. Amgen illustrates how a company can achieve the transition from being at the development stage — ‘socialised mind’ — to be able to begin systems orientation — ‘self-authored’.
However, he revealed that the legacy practices and the inherent uncertainty in measurement systems for physical attributes can serve as a 2–3 sigma barrier in the synthetic drug product sector. It is this barrier that contributes to high OOS rates and high rates of invalidated OOS, in his opinion. This metric is sought by the FDA from the industry and serves as a blind spot.
“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,” said Chris Kilbee, group director, Pharma Portfolio at UBM EMEA. “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.”