CPhI Worldwide has announced the findings of the final section (part iii) of the 5th 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 was published live from CPhI Worldwide in Frankfurt (24 to 26 October 2017) 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 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 explained, "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 two to three years."
He added, "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."
Alan Sheppard, principal of Global Generics at IMS Health, suggested in his article that there are still good opportunities for biosimilars in the industry. In the past, he claimed, biosimilars were often viewed as a "risky venture" for pharmaceutical companies, but now could be the ideal time to invest. He added, "The uptake of the latest biosimilars in Europe is extremely positive and is starting to track the dynamics of small molecule products."
Sheppard emphasised that it is not too late for pharma companies that have yet to get involved in the biosimilar market either, "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, 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 regulat...
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