In early April, Delaware became the first state to pass a biosimilar law, allowing a retail pharmacist to substitute or interchange a biosimilar product for an originator biological product if the prescriber did not prohibit a substitution.1 The law requires the pharmacist to record information on the label and dispensing record of the substitution, inform the patient of the substitution and also notify the prescriber of the substitution within 10 days of doing so. All related pharmacy records must be kept for at least three years.
Key points of the legislation include transparency and open lines of communication between patients, prescribers and other members of the healthcare team (e.g., pharmacists). The Biotechnology Industry Organization and the Delaware BioScience Association support the legislation; however, the Biologics Price Competition and Innovation (BPCI) Act of 2009 conflicts with the new legislation because it states that an interchangeable biological product may be substituted for the reference product without healthcare provider intervention. The Generic Pharmaceutical Association believes that because the Food and Drug Administration (FDA) has yet to pass final biosimilar guidance, individual state legislation (such as this) is not currently necessary.
Colorado, Florida, Indiana and North Dakota have all passed similar legislation.2,3 The BPCI Act became law in 2010 and established an abbreviated approval pathway for biological products that are confirmed to be “highly similar” to (biosimilar) or “interchangeable” with an FDA-approved biological product.4
Six states have failed to pass biosimilar legislation (i.e., Arizona, Arkansas, Maryland, Mississippi, Texas, Washington), and five states (i.e., California, Colorado, Illinois, Massachusetts and Pennsylvania) are considering legislation.
In the U.S., only around 5% of the total volume of top biological products are distributed by retail pharmacies. As previously noted (see the February 2014 article on biosimilars in this publication), other countries are much further ahead of the U.S. in relation to biosimilar approvals. Most recently, on April 17, the Russian Ministry of Health approved Biocad’s biosimilar rituximab (AcellBia; BCD-20) to Roche Laboratories MabThera/Rituxan.5
Pipeline & Drug Approvals
Celecoxib (Celebrex) may see its U.S. debut later this year due to a patent settlement between Teva Pharmaceuticals generic division and Pfizer Inc.6 The branded product continues to have blockbuster status, having U.S. sales greater than $2 billion in 2013.
Gevokizumab, a once-monthly, antiinflammatory, monoclonal antibody injection in Phase 2 clinical trials for the treatment of erosive osteoarthritis of the hand, will no longer be studied for this indication due to weak efficacy results.7,8 Gevokizumab currently has orphan drug status for treating pyoderma gangrenosa, Behçet’s uveitis and noninfectious uveitis. Other indications are being sought.