Biosimilars are basically the generics or copies of biological medicines.The first FDA approved biosimilar was last January and was the biosimilar (filgrastim-sndz) to Neopen (filgrastim). Though filgrastim-sdnz is new to the U.S., copies have been available in the EU since 2009.
Biologics (Humira, Rituximab, Neopogen, etc) are large, complex molecules that are made from living organisms. Because of the nature of biologics, they are much harder to replicate, hence the name "similar".Biologics and biosimilars are produced in living cells with a multi-step process
Biosimilars differ from generics – in complexity, in the manufacturing processes and in the data needed to demonstrate similarity for approval
Role of the Pharmacist
Should know about the validity of extrapolating data from the innovator product to the biosimilar requires careful evaluation of the available data, especially immunogenicity data.
Health-system pharmacists can provide valuable input into decisions about use of biosimilars in the institution based on available clinical data.
A Health-System pharmacist’s Guide to Biosimilars: Regulatory, Scientific, and practical considerations biosimilar designation was established by FDA.
Pharmacovigilance: Health-system pharmacists play a vital role in the pharmacovigilance needed to detect, assess, and prevent adverse effects and other drug-related problems from biopharmaceuticals.
Health-system pharmacists can play an important role in ensuring the safe, effective, and cost-effective use of biosimilars in health systems.
As pharmacists, we need to educate our patients, physicians and other health care providers about the benefits (and possible risks) of biosimilars.
Pharmacists will need to understand the differences in all of the approval pathways to educate physicians and other clinicians on the labeling associated with each medication and the manner in which they should be used.
Pharmacists will be expected to provide leadership and guidance in balancing the financial and clinical issues associated with formulary decisions and the selection and use of these products.
Health system pharmacists whose practice settings include outpatient environments should be aware of their state’s requirements for pharmacy concerning biosimilars.
Basic information pharmacists and other clinicians must know to successfully manage the introduction of biosimilars into health systems is summarized, including manufacturing, regulatory, and medication use policy concepts.
As stewards of appropriate medication use, pharmacists must take the initiative to educate themselves, physicians, other clinicians and patients on these products to ensure an accurate understanding of this new category of drugs and to assure the safe and optimal use of biosimilars
Health-system pharmacists should take a leadership role in a multidisciplinary effort to evaluate biosimilars for use in the institution through the formulary process.
Know about the cost advantages of biosimilars may enter into formulary decisions.