Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead

CPhI Worldwide (organized by UBM) announced last fall the final section findings of the fifth edition of the CPhI Annual Report. Presented live at the meeting in Frankfurt, Germany, the report is now available online. It highlights immediate and long-term trends in pharmaceutical data, regulation, generics, and biosimilars. Four experts gave their views.

They warned that the US Food and Drug Administration’s (FDA) approach to achieving six-sigma (nearly perfect or 99.9997% defect-free) quality is failing in respect to the pharmaceutical industry’s self-adoption of continuous quality systems, making regulatory oversight imperative. One positive note was identified in the current regulatory approach to data standards and analysis. It could lead, for example, to investments in handling “big data” that could revolutionize drug discovery and patient treatment over the coming decade.

A Contentious Relationship
The report also notes that, despite what one expert described as “abusive and unethical antics” of innovator companies, biosimilar development continues. With anticipated US–European harmonization in regulatory guidelines and rising numbers of players, biosimilar market dynamics are shifting to accelerate adoption of such products.

Dilip Shah (CEO of Vision Consulting Group) predicted how he sees the intense battle between innovators and “biogeneric” companies playing out over the next three years. The tide is turning gradually in favor of the latter, he said, thanks to pressure from patients on governments. Shah believes that innovators impede the progress of companies producing both generics and biosimilars through “morally dubious practices,” yet he does not feel that those methods will succeed in slowing down that progress. “The innovator companies will face increasing pressure to ensure access to medicines at affordable prices,” he explained. “Regulators and governments will force them to facilitate development of biogeneric versions over the next two to three years.”

Alan Sheppard (principal of Global Generics at IMS Health) suggested that good opportunities abound for biosimilar developers. Until recently, he said, biosimilars had been viewed as a “risky venture” for pharmaceutical companies — but now could be the ideal time to invest. Sheppard emphasized that it is not too late for companies that are not yet involved in the biosimilars market. “As with small chemical molecules,” he said, “biosimilar developers are seeking partners for marketing and distribution and contract manufacturing organizations with biosimilar capabilities.”

Drugs and Data: Quality is Key
Bikash Chatterjee (president and chief science officer of Pharmatech Associates) declared that the emergence of a global marketplace with shared regulatory compliance is one of many factors driving change in pharmaceutical regulation. A key element is adoption of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) by 50 regulatory entities around the world (with 70 more expected to join by 2020). Important US legislation includes the 2016 21st Century Cures Act.

Thanks to new high-throughput technologies — notably next-generation sequencing — Chatterjee said that data illustrating performance and compliance will increase in importance over the coming decade. Improvements in big-data analytics will be crucial in highlighting the most suitable candidate drugs based on “e-clinical,” lifestyle-diagnostic, and digital-health initiatives. All this highlights the importance of cyber security, especially as the industry becomes more dependent on patient data for drug development than ever before. “The industry’s ability to manage constantly evolving threats to data management and integrity will define how we develop new drug therapies in the future,” Chatterjee said.

Ajaz Hussain (founder of Insight, Advice & Solutions LLC) explored the perpetual gap between what we know and what we can practice and implement. Using Amgen as a case study, he showed how a company can reach six-sigma quality (with an error rate of 3.4 defects per million units). Legacy practices (e.g., compendial test methods for batch-release testing) and inherent uncertainty in measurement systems for physical attributes (e.g., dissolution tests) act as “self-imposed two- to three-sigma barriers” for the synthetic drug-product sector. That contributes to high rates of out-of-specification (OoS) and invalidated OoS results, which is a metric that the FDA is beginning to encourage. Such barriers often create unrecognized blind spots in a company’s vision.

For more detailed discussions, you can download a copy of CPhI Annual Report 2017 — released at CPhI Worldwide in Frankfurt (24–26 October 2017) — online at www.cphi.com/europe/cphi-annual-report.

Alison D. Center is an editorial assistant for BioProcess International ([email protected]).