Last year the U.S. Food and Drug Administration approved the first ever biosimilar drug for use in the U.S. and is expected to approve another this year. A biosimilar of a biologic drug is often likened to a generic version of a brand name chemical drug. The main differences are that biologics are much larger, more complex, and they cost a lot more money to develop and produce than small molecule chemical drugs (approximately $100-250 million vs. $2-3 million respectively). A biosimilar is an inexact replica of a biologic drug. Since biologics are produced by unique cell lines and are composed of thousands of atoms, exact replicas from other companies (like generics) are nearly impossible. So a biosimilar drug is one that has similar chemical, therapeutic, and side effect profiles as its reference biologic, but it is not exact, allotting it the potential to interact differently in patients. Biologics are important innovations that are indicated for some of the most difficult to treat diseases like Crohn’s, rheumatoid arthritis, and cancer. They have been widely used in Europe for over a decade, but the U.S. has been reluctant to follow suit. However, as the benefits of biologics continue to be elucidated and their demand increases, patients and healthcare providers have become unnerved as they continue to see exorbitant price increases (costs of cancer biologics doubled from 2006 to 2012). Moreover, due to the nature of biologics, many of them do not see competition or price reductions after their patents expire, as small molecule drugs do—perpetuating the high prices and price increases. This has created a demand for biosimilars in the U.S. that can no longer be ignored. As the FDA continues to roll out guidelines for biosimilar naming and approval criteria, we should expect an influx of biosimilars on the market in the coming years. The hope is that the increased competition will drive down healthcare costs and make these therapies more accessible to more patients. It will also create new opportunities within the pharmacy profession for innovation and influence over how these drugs are regulated, administered, and priced. As approvals increase, we should expect regulations to increase as well. Pharmacists’ input will be invaluable to the discussions over legislation of biosimilars. On the clinical and community scales, it is currently the pharmacist’s choice whether to recommend a generic over a name brand medication, but what will be our input when the “generic” biosimilar is not chemically identical to the brand name? When the biosimilar has a different side effect profile? It will also specifically open the door for managed care pharmacists to assert their expert knowledge and skills when insurance companies and hospitals must construct and negotiate a payment structure for this new class of drug. Lindsay AdairVP of Membership
0 Comments
Leave a Reply. |
Have an exciting topic about the managed care space or pharmaceutical industry you would like to share?
Showcase your writing skills and have your post featured in the AMCP-OSU Blog by reaching out to the VP of Communications, Pia Georgette Ang. Archives |