Adapting to New Biosimilar Regulations and Advancing Success

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.  The recap for Day 1 of Business of Biosimilars and Generic Drugs is here.

A presentation by Ms. Suzanne Sensabaugh, CEO Hartman Willner, LLC covered the FDA’s current definitions of comparable, equivalent, and interchangeable with respect to biosimilars. Under section 351k and 351a pathways exists for approval of a biosimilar, highly similar interchangeables and biobetters. Where an interchangeable must be shown to have the same clinical effects if switched with the innovator. The biobetter pathway 351a is different in many ways from that of the biosimilar 351k pathway. A therapy seeking biobetter designation cannot be labeled as a biosimilar or an interchangeable. The biobetters use placebo or standard of care for either superiority or non-inferiority studies. In addition, reference products approved outside of the US can be used as a standard if analytical testing shows similarity. The 351a process for biobetter development also requires manufacturers to conduct clinical studies for all indications, and toxicology and pharmacology testing (can be reduced testing options per FDA), and clinical trials (data can be included on the label). As for payments, the user fees for biobettrs are due at BLA filing, where biosimilar user fees are due at the pre-IND meeting. Because of the increased stringency in biobetter development this usually takes 15 years to gain approval compared to the 7 years for biosimilars.

Steven Lucio, Director Pharmacy Clinical Solutions, Novation a healthcare supply chain organization offered insights into the product awareness and acceptance of generic drugs and what biosimilars will need to consider when battling this hurdle in getting acceptance of biosimilars from doctors, pharmacies, and the general public. He showed data of how generics approvals have resulted in a steady decrease in annual drug expenditures from 1998-2011. However, he also showed how these approvals have also contributed to the national drug shortages since the inception of generic drugs from 2001-2012. He also outlined the generally acceptability and ease of uptake of generic drugs where in most cases interchangeability is a nonissue, except in cases of highly sensitive clinical populations. An example, was used in therapies for mood stabilizers, anticoagulants, hormones, bronchidilators, antiepileptic drugs, and antiarrythmics. These therapeutic areas often have patient populations that are elderly, women, pediatric, immunocompromised, or have acute coronary syndromes. As for the biosimilars market it is imperative that manufacturers develop a greater recognition of best practices and adopt these practices during product development , manufacturing, and regulatory approvals. In addition, increased publications discussing biosimilars provide an easier clinic to pharmacy acceptance.

Novation is actively engaging in activities to provide biosimilar support strategies by way of publishing two white papers, speaking engagements, drug monographs, cross reference charts, pricing forecasts, and therapeutics class reviews of therapies in the pipeline which provides information on therapies in the pipeline.

The final presentation for the conference was by Hans Sauer, Associate Counsel for IP, BIO and Bruce Leicher, Senior VP and /general Counsel, Momenta. The mainly discussed the patent exchange process and what biosimilar developers need to keep in mind during this short and many times stressful time. They mentioned many of the same pitfalls discussed by Mark Hyman, of Human Genome Sciences and others regarding preparing a litigation strategy long before the new drug application is submitted to the FDA and the innovator company. There were also discussions as to whther the term “shall” does actually compel a biosimilar developer to disclose its NDA to the innovator company for review of patent infringement. However, this would leave the biosimilar company open for litigation and at a possible disadvantage in the judiciary depending on the judges interpretation of the statute.

In addition to the presentations at this years meeting there were also demonstrations of novel devices that can be partnered with biosimilars to offer added advantages to delivery of therapies. One such example, is the DosePro system from Zogenix which is a commercially available prefilled disposable needle free drug delivery system for subcutaneous injection. A brief demonstration was done by John Turanin, VP and General Manager, Zogenix to show its ease of use and potential for use in the biosimilar development. Additional information regarding the DosePro Technology and the company Zogeneix can be found by clicking the following link: http://www.zogenix.com/

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