Visit Contract Pharma
at Stand No. 1G97

CPhI Report Addresses Battle Between Innovators and Biogenerics


Regulation shifting due to increased data dependence, regulatory oversight is slowing six sigma, forecasts generic growth

CPhI Worldwide has released the findings of part III of its annual report  focused on the immediate and long-term trends in pharmaceutical data, regulation, generics and biosimilars. The report includes contributions from four experts in data, regulation, generics and biosimilars: Dilip G. Shah, Alan Sheppard, Bikash Chatterjee, and Ajaz S. Hussain.
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 advance over the next decade. For example, investments in handling big data will allow the industry to mine insight into historical performance and enable insight from e-clinical and post-market initiatives more effectively.
The report also noted that the development of biogenerics is continuing to grow, and with the anticipated harmonization of biosimilar regulatory guidelines for both the U.S. and Europe, we should see an overall increase in players in the market, and the acceleration of generics and adoption. 
Dilip G. Shah, chief executive officer of Vision Consulting Group, said the battle between innovators and biogeneric companies is likely to play out over the next three years, and that the tide is now gradually turning in favor of generic companies. Mr. Shah said, “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. The 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 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.
Mr. Sheppard said, “As with small chemical molecules there now exists biosimilar developers who are seeking partners for marketing and distribution and contract manufacturing organizations 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 21st Century Cures Act in late 2016 authorized new drug and device manufacturers to utilize real-life data to establish drug safety and efficacy for FDA approval.
As a consequence of new high-throughput technology, notably next-gen sequencing, Mr. 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, he 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, Ph.D., 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 21st century initiative – remains. He explores how Amgen (as a case study) reached six sigma with an error rate of just 3.4 defects per million opportunities. Dr. Hussain stresses 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.