Innovations and New Approaches for Biological Drugs

Presenters delved into the topic of biological drugs and gene therapy during the recent International Pharmaceutical Federation (FIP) World Congress in Glasgow Scotland. This discussion focused on the process of taking new technologies and approaches in pharmacotherapy from conception to implementation. Also addressed in this session were the costs and safety aspects in this rapidly growing realm.

The first speaker, Susan Cantrell, Rph, CAE, and CEO of the Academy of Managed Care Pharmacy, introduced some of the safety and cost aspects of concern in this field. One of the bigger challenges facing many biosimilar products coming to market is the same stigma that often leads to prescribers and patients shunning generic medications, despite potential costs savings. There is still concern that a biosimilar product may not have the same efficacy or safety as the original biologic product. In fact, a recent survey indicated 75% of prescribers had these concerns when asked about switching products.

Intellectual property rights disputes and commercializing products amidst long term contracts between manufacturers and insurers are additional challenges, according to Cantrell. Despite these issues, the emergence of a strong biosimilar market could result in a significant health care costs saving of 45 to 50 billion dollars by 2027, based on projections.

The second speaker, Prateek Jain, PhD, from Decision Resources Group, India focused on the importance of having mechanisms in place to move medications down the pipeline more quickly. As many biological products are used in very small patient populations, it is often important to have a faster approval process in place in order to bring them to market.

Jain began his talk by identifying the various pathways the FDA has in place to bring products to market more quickly. He detailed the 4 expedited pathways: fast-track designation, accelerated approval, priority review, and breakthrough therapy designation. The goal of these programs is to shorten drug-development timelines and promise new medications to suffering patients. Although expedited processing facilitates earlier access of drugs that are urgently needed by specific patient populations, there is some concern that it may undermine safety. While there have been a few cases where products have been withdrawn from the market, overall Jain said he believes that having these options in place is vital in providing compassionate health care.

Finally, the topic of interchangeability issues in regards to biosimilars was addressed by Iqbal Ramzan from The University of Sydney. The dynamic and interaction of pharmacist and physicians in identifying equivalency issues and costs were discussed. The talk addressed scientific, clinical, policy, and regulatory issues surrounding biologics and biosimilars.

Ramzan identified what knowledge pharmacists will need moving forward when discussing interchangeability principles with other health care professionals. Pharmacists will require an understanding of physicochemical tests needed to establish equivalence, efficacy, safety, and clinical risks of switching, not only from an originator biologic to a biosimilar, but from any biologic compound to another.

Lastly, there are also practical considerations such as dosing schedules and method of administration that should be considered in addition to efficacy, safety and cost when deciding on specific agents.