Amsterdam, 24th October 2017: CPhI Worldwide – organised by UBM – announces the findings of 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 (October 24-26, 2017) amongst more than 42,000 executives.
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 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 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.
Alan Sheppard, Principal of Global Generics at IMS Health, suggests in his article that there are still good opportunities for biosimilars in the industry. He 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.”
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).
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 21st century initiative – remains. Utilizing the constructive development theory of adult human development, he explores how Amgen reached six sigma with an error rate of just 3.4 defects per million opportunities.
